Clinical Trials
(ACT011)
A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
Chair:
Dr. Herbert Loong
Eligibility:
Patients with RET-Fusion Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, and Other Tumors with Increased RET ActivityObjectives:
Primary Objectives:(Phase 1 part) To determine MTD/recommended phase 2 dose ofLOXO292.
(Phase 2 part) To assess, for each phase 2 expansion cohort, the anti-tumor activity of LOXO-292.
Secondary Endpoints:
- To determine safety profile and tolerability, characterize PK properties, toxicities and preliminary anti-tumor activity of LOXO-292
Exploratory Objectives:
- To determine relationship between PK and drug effects.
- To evaluate the serum tumor markers before, during, and at the end of treatment with LOXO-292 (for thyroid cancers patients only)
- To characterize RET gene fusions and mutations by molecular analysis
- To collect patient reported outcomes (PRO) data to explore disease-related symptoms and health-related quality of life (HRQoL).
(ACT015)
A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)
Chair:
Dr. Herbert Loong
Objectives:
The aim of study is to provide access to LOXO-292 for patients with locally advanced or metastatic solid tumors with activating RET alterations (and other evidence of RET activation) who are 18 years of age or older and to determine the safety profile and tolerability of LOXO-292.
(ACT016)
An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib
Chair:
Dr. Herbert Loong
Eligibility:
Inclusion Criteria (PDF):Exclusion Criteria (PDF):
Objectives:
Primary Objectives:To evaluate long term safety data (SAEs and AEs) by measuring the frequency and severity of AEs/SAEs
Secondary Objectives:
To evaluate clinical benefit as assessed by the investigator by measuring the proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
(ACT017)
A Phase 1/2, Open-Label, Multi-Center, First-in-HumanStudy of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity ofTPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3Rearrangements
Chair:
Dr. Herbert Loong
Eligibility:
1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, ALK or NTRK1-3 gene fusion.2. Subjects must have a documented ROS1, ALK orNTRK1-3 gene fusion that has been identified by local testing AND that has been prospectively confirmed by a central diagnostic laboratory to determine molecular eligibility PRIOR to enrollment.
Objectives:
- ORR, as assessed by BICR usingRECIST 1.1, in each subject population expansion cohort
- The DOR, TTR and CBR will be assessed by BICR using RECIST 1.1
- The PFS and OS will be assessed by BICR using RECIST 1.1
- Intracranial ORR and CNS-PFS will be assessed by BICR
- Type, incidence, severity, timing, seriousness, and relatedness of AEsand laboratory abnormalities
- Pharmacokinetic parameters of repotrectinib
- Changes in Quality-of-Life andhealth status during repotrectinib treatment
(ACT020)
An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments
Chair:
Prof. Brigette Ma
Eligibility:
- Signed informed consent must be obtained prior to participation in the study.
- Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment.
- Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.
- Subject has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Subject is willing and able to comply with the scheduled visits and treatment plans.
Objectives:
To collect safety and tolerability data for spartalizumab as single agent or in combination with other study treatments. To allow subjects enrolled in a spartalizumab Novartis-sponsored study continued access to study treatment.
(ACT030)
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation (CJDQ4433A12101)
Chair:
Dr. Herbert Loong
Eligibility:
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received and failed standard of care therapy or are intolerant or ineligible to approved therapies, willing to undergo a tumor biopsy at screening if medically feasible.Objectives:
To assess the safety and tolerability of JDQ443 single agent and JDQ443 in combination with TNO155, JDQ443 in combination with spartalizumab, and JDQ443 in combination with TNO155 and spartalizumab, and to identify the maximum tolerated dose and/or recommended dose and regimen for future studies..
(ACT034)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (Tapistry) Phase II Platform Trial
Chair:
Dr. Herbert Loong
Eligibility:
Patient must have NGS test result with histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy. Patients must have reasonable hematologic and liver and renal function.Objectives:
To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1).
(ACT036)
A phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab in patients with select advanced cancers
Chair:
Prof. Brigette Ma
Eligibility:
1. Adult patients with advanced or metastatic disease who have progressed despite having received standard therapy in the metastatic setting or are intolerant to standard therapy, and/or for whom effective standard therapy is not available.2. Patients with non-small cell lung cancer, renal cell carcinoma, and cutaneous melanoma, who have received prior anti-PD-(L)1-containing therapy, and patients with ovarian cancer, nasopharyngeal cancer, anal cancer, thymic carcinoma, MSI-H colorectal cancer (CRC), esophagogastric cancer, mesothelioma, or head and neck squamous cell carcinoma (HNSCC), who are naive to anti-PD-(L)1 therapy will be included in the trial.
3. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines.
Objectives:
To characterize the safety and tolerability, and preliminary anti-tumor activity of KFA115 in combination with tislelizumab in patients with select advanced cancers.
(ACT038)
A phase 1/1b/2 study of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
Chair:
Dr. Herbert Loong
Eligibility:
- Evidence of homozygous loss of CDKN2A (null) (Parts 1a and 1b only) and/or MTAP (null) in the tumor tissue or blood (Parts 1a to 1h, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1h, Parts 2a and 2b).
- Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
- Squamous/ adenocarcinoma NSCLC, cholangiocarcinoma, HNSCC, pancreatic adenocarcinoma.
Objectives:
- Parts 1 and 2
- To evaluate the safety, tolerability, and to determine the MTD or RP2D of AMG 193 alone and in combination with docetaxel in adult subjects with metastatic or locally advanced MTAP-null solid tumors.
- To characterize the PK of AMG 193 alone and in combination with docetaxel. To evaluate ORR, DCR, DoR, TTR, duration of SD, PFS, and OS of AMG 193 alone and in combination with docetaxel in adult subjects with MTAP-null solid tumors.
- To evaluate the effect of Drug Substance Particle Size (DSPS) on the oral PK of AMG 193 in Part 1 (optional substudy, US only). - Part 3
- To evaluate the ORR of AMG 193 in adult subjects with metastatic or locally advanced MTAP-null non-small cell lung cancer NSCLC, after prior treatment with chemotherapy and/or a PD-L1 inhibitor.
- To assess safety and tolerability of AMG 193 in metastatic or locally advanced MTAP-null NSCLC.
- To evaluate DCR, DoR, TTR, duration of SD, PFS, and OS of AMG 193 in metastatic or locally advance MTAP-null NSCLC.
(ACT039)
A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation
Chair:
Dr. Herbert Loong
Eligibility:
• Histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.• ECOG performance status of 0 – 1
• Measurable disease per RECIST v1.1
• Documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood
• Have received at least 1 line of prior SOC systemic therapy for locally advanced and unresectable or metastatic disease.
• NSCLC (Cohorts 2a and 2b), CRC (Cohort 2c-1), Pancreatic cancer (Cohorts 2c-2):
• Must have archived tumor tissue samples or be willing to undergo a pretreatment tumor biopsy prior to first dose of study medication.
Objectives:
• Evaluate the safety and tolerability of D3S 001 in adult subjects with KRAS p.G12C mutant solid tumors• Determine the maximum tolerated dose (MTD), if applicable, and the recommended phase 2 dose (RP2D)
• Characterize the PK of D3S 001 following administration as an oral capsule formulation
• Evaluate the effect of food on the oral pharmacokinetics of D3S 001
• Evaluate tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) +v1.1 of D3S 001 as monotherapy in advanced solid tumors with a KRAS p.G12C mutation
(ACT041)
A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination with Pembrolizumab (Anti-PD-1 Antibody) in Patients with Advanced/Metastatic Solid Tumors
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically metastatic solid tumors. Patient must have adequate hematological, liver and renal function.Objectives:
To assess the preliminary antitumor activity of ADG126-pembrolizumab combination regimen.
(ACT042)
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion – Master Protocol
Chair:
Prof. Stephen Chan
Eligibility:
Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas without prior systemic therapy for metastatic or unresectable disease. Homozygous MTAP-deletion as assessed by local or central NGS testing. Patient should have adequate liver and renal function.Objectives:
Primary:- To determine the maximum tolerated dose (MTD) or recommended combination dose of AMG 193 administered in combination with gemcitabine and nab-paclitaxel or with mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deleted Pancreatic Ductal Adenocarcinoma (PDAC)
- To determine the safety profile of AMG 193 administered in combination with gemcitabine and nab-paclitaxel or with mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deleted PDAC
Secondary:
- To evaluate the anti-tumor activity of AMG 193 administered in combination with gemcitabine and nab-paclitaxel or with mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deleted PDAC
- To characterize the pharmacokinetics (PK) of AMG 193 administered in combination with gemcitabine and nab-paclitaxel or with mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deleted PDAC
Exploratory:
- To investigate biomarkers associated with clinical response to AMG 193 in subjects with MTAP-deleted PDAC
- To investigate molecular mechanisms of resistance to AMG 193 in subjects with MTAP-deleted PDAC
(ACT043)
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER)
Chair:
Prof. Stephen Chan
Eligibility:
(Cohort 2F only) Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology. Patient should not receive prior systemic treatment for HCC and has adequate hepatic and renal function.Objectives:
Primary:- To evaluate the anti-tumor activity of TSR-022 in combination with TSR-042 in patients with solid tumors, in terms of ORR as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary:
- To evaluate the safety and tolerability of cobolimab + dostarlimab in HCC
- Overall survival (OS) for patients
- Alpha-fetoprotein (AFP) response
Exploratory:
- To characterize the PK of Cobolimab and Dostarlimab
- To evaluate the immunogenicity of Cobolimab and Dostarlimab in Part 2F
- To characterize the Pharmacodynamic profile of TSR-022 and
- in combination therapy with TSR-042
- To explore changes in biomarkers (e.g., immune cells and immune proteins) in the tumor and circulating biomarkers in the blood following treatment with TSR-022 and correlate with clinical benefit
- To further evaluate additional measures of clinical benefit including:
- ORR by irRECIST
- DOR by irRECIST
- DCR by irRECIST
- PFS by irRECIST
- ORR by RECIST v1.1 in comparison to patients in Sorafenib ECA
(BRE034)
A Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), an anti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane (DESTINY-Breast03)
Chair:
Prof. Winnie Yeo
Eligibility:
Patient with pathologically documented breast cancer that is unresectable or metastatic and has confirmed HER2-positive expression and patient must have reasonable hematological and renal and liver function.Objectives:
Primary Objective:- The primary objective is to compare the efficacy of DS-8201a to T-DM1 on PFS.
Secondary Objectives:
- To further compare the efficacy of DS-8201a compared to T-DM1 on: OS, ORR, DoR and Clinical benefit rate.
(BRE039)
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy
Chair:
Prof. Winnie Yeo
(BRE045)
A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)
Chair:
Prof. Winnie Yeo
(BRE046)
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Chair:
Prof. Winnie Yeo
Eligibility:
Key Inclusion Criteria:Either one of the following:
- Radiographic disease progression on one or more lines of endocrine therapy with one in combination with a CDK4/6 inhibitor
- Radiographic disease progression within 6 months of starting 1L endocrine therapy in combination with a CDK4/6 inhibitor that was prematurely discontinued (before experiencing radiologic disease progression due to intolerance)
- Radiographic disease progression >/= 6 months of starting 1L endocrine treatment in combination with a CDK4/6 inhibitor that was prematurely discontinued (before experiencing radiologic disease progression due to intolerance) AND Radiographic disease progression on an additional (2nd) endocrine therapy
- Relapsed during, or within 12 months of completing adjuvant endocrine therapy with a CDK4/6 inhibitor
- For ER-low positive tumor (ER 1-10%): previous therapy with CDK4/6 inhibitors and/or Endocrine Therapy is permitted but not required.
Key Exclusion Criteria:
- Has breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (<6 months after completing adjuvant therapy) and therefore is eligible to receive second line treatment
- Has a known ESR1 mutation and has not received previous treatment with elacestrant (where available and not medically contraindicated)
- Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition either in the adjuvant or metastatic setting (where available and not medically contraindicated)
- Has Grade ≥2 peripheral neuropathy
- Has received prior chemotherapy for unresectable locally advanced or MBC
- Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days before the first dose of study intervention and throughout the study
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Note: Participants previously treated with endocrine therapy plus a targeted agent (e.g., mTOR or PI3K or CDK4/6 inhibitors) may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
Objectives:
Primary objective:To compare
- MK-2870 to TPC
- MK-2870 plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants
Secondary objective:
To compare
- MK-2870 to TPC
- MK-2870 plus pembrolizumab to TPC
- MK-2870 plus pembrolizumab to MK-2870 with respect to OS in all participants
(BTC005)
A Phase III Randomized, Double-Blind, Placebo-Controlled,Multi-Regional, International Study of Durvalumab in Combination withGemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plusCisplatin for Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1)
Chair:
Prof. Stephen Chan
Eligibility:
Adult patient must have histologically confirmed biliary tract cancers without prior systemic therapy. Patient also needs to have reasonable hematological and renal and liver function.Objectives:
To evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate and poor-risk advanced or metastatic RCC
(BTC008)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
Chair:
Prof. Stephen Chan
Eligibility:
Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic CCA or muscle invasive GBC) who have undergone macroscopically complete resection with curative intent (R0 or R1) within 12 weeks of randomization. Patient should not receive prior systemic treatment. Patients should have adequate hepatic and renal function.Objectives:
Primary:- To demonstrate superiority of rilvegostomig + chemotherapy relative to placebo + chemotherapy by assessment of RFS in participants with BTC after resection with curative intent
Secondary:
- To demonstrate superiority of rilvegostomig in combination with chemotherapy relative to placebo in combination with chemotherapy by assessment of OS in participants with BTC after resection with curative intent
- To assess patient-reported tolerability (overall bother, physical functioning, symptoms) in participants with BTC after resection with curative intent treated with rilvegostomig in combination with chemotherapy compared to placebo in combination with chemotherapy
- To assess the efficacy of rilvegostomig in combination with chemotherapy compared to placebo in combination with chemotherapy by PD-L1 expression in participants with BTC after resection with curative intent
- To assess the efficacy of rilvegostomig + chemotherapy compared to placebo + chemotherapy by assessment of PFS following recurrence in participants with BTC after resection with curative intent
- To assess the PK of rilvegostomig when used in combination with chemotherapy in participants with BTC after resection with curative intent
- To investigate the immunogenicity of rilvegostomig in participants with BTC after resection with curative intent
Exploratory:
- To collect and assess blood and tumor samples for biomarker analysis in participants with BTC after resection with curative intent treated with rilvegostomig or placebo in combination with chemotherapy
- To investigate the relationship between circulating factors and efficacy outcomes
- To assess maintenance of physical functioning, role functioning, and HRQoL
- To assess maintenance of physical functioning assessed via CAT
- To explore the impact of treatment and disease state on health state utility using the EQ-5D-5L
- To explore the impact of treatment and disease on health care resource use
(BTC009)
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
Chair:
Prof. Stephen Chan
Eligibility:
Histologically or cytologically confirmed, locally advanced, metastatic, unresectable intrahepatic cholangiocarcinoma (iCCA) or extrahepatic cholangiocarcinoma (eCCA). Documented evidence of FGFR2 gene fusions or other rearrangements by local testing using next-generation sequencing (NGS) or fluorescence in situ hybridization (FISH). Received at least one prior systemic gemcitabine and platinum-based regimen for CCA. Patient should have adequate liver and renal function.Objectives:
Primary:- To assess the efficacy of futibatinib administered at 20 mg and 16 mg QD to verify and describe the clinical benefit
Secondary:
- To evaluate further efficacy parameters of futibatinib administered at 20 mg and 16 mg QD
- To evaluate the safety and tolerability of futibatinib administered at 20 mg and 16 mg QD
- To evaluate Patient Reported Outcomes (PROs)
Exploratory:
- To investigate the PK and dose- and exposure-response relationships for efficacy and safety of futibatinib administered at 20 mg and 16 mg QD
- To assess FGF/FGFR aberrations and concurrent molecular alterations and its association to tumor resistance to futibatinib
(COL026)
A randomized study ofneoadjuvant chemoradiotherapy with or without intensification with theFOLFOXIRI chemo-regimen for high-risk locally advanced rectal cancer
Chair:
Prof. Brigette Ma
Eligibility:
Histologically proven locally advanced rectaladenocarcinoma without distant metastasis. Patients must not have priortreatment with Oxaliplatin or Irinotecan. Patient should also have adequatehaematologic, renal and hepatic function.Objectives:
Pathologic complete response rate
(COL030)
A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed adenocarcinoma with recurrent, unresectable or metastatic disease. Patient must have adequate hematological, liver and renal function.Objectives:
To determine if amivantamab + FOLFIRI will demonstrate superior PFS or OS compared with cetuximab or bevacizumab + FOLFIRI as second-line treatment in adult participants with KRAS/NRAS and BRAF WT recurrent, unresectable or metastatic colorectal cancer who have received prior chemotherapy.
(GAT013)
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with dvanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Chair:
Prof. Winnie Yeo
Objectives:
Primary Objective:Objective (Part 1): To evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab plus chemotherapy.
Objective (Part 2): To compare the overall survival between treatment groups
Hypothesis (H1): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for OS in participants with programmed cell death ligand 1 combined positive score ≥1.
Hypothesis (H4): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for OS in all participants.
Objective (Part 2): To compare the PFS between treatment groups
Hypothesis (H2): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for PFS per RECIST 1.1 as assessed by BICR in participants with programmed cell death ligand 1 combined positive score ≥1.
Hypothesis (H5): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for PFS per RECIST 1.1 as assessed by BICR in all participants.
(GAT014)
A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen (DESTINY-Gastric04)
Chair:
Prof. Winnie Yeo
Objectives:
Primary Objective:To compare OS in HER2-positive (defined as IHC 3+ or IHC 2+/ISH+) GC and GEJ subjects treated with T-DXd vs. Ram + PTX.
Secondary Objectives:
- To compare PFS in HER2-positive GC and GEJ adenocarcinoma subjects treated with T-DXd or Ram + PTX.
- To evaluate further the clinical efficacy of T-DXd and Ram + PTX by ORR based on Investigator assessment
(GAT015)
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
Chair:
Prof. Winnie Yeo
Objectives:
Primary endpoint:- OS in FGFR2b ≥10% 2+/3+ TC
Key secondary endpoint:
- PFS, OR in FGFR2b ≥10% 2+/3+ TC
Other secondary endpoints:
- Any AEs, clinically significant changes in vital signs visual acuity, and clinical laboratory results
- OS, PFS and OR in all randomized subjects
- Pharmacokinetic parameters
- DOR
- QoL
- Immunogenicity
(GAT017)
A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician’s Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)
Chair:
Prof. Winnie Yeo
Objectives:
Primary objective:- To compare MK-2870 to TPC with respect to OS
Secondary objectives:
- To compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR
- To compare MK-2870 to TPC with respect to OR per RECIST 1.1 as assessed by BICR
- To compare MK-2870 to TPC with respect to DOR per RECIST 1.1 as assessed by BICR in participants who demonstrate confirmed CR or PR during or after treatment with study intervention
- To evaluate the safety and tolerability of MK-2870
(GIS001)
(Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Chair:
Dr. Herbert Loong
Eligibility:
Patients with locally advanced, metastatic, and/or unresectable GIST, and have received prior therapy with imatinib. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To determine the efficacy and evaluate efficacy Parameters of bezuclastinib +sunitinib vs sunitinib in subjects with GIST
(HCC055)
A Phase 3, Randomized, Double-blind Study ofAdjuvant Nivolumab versus Placebo for Participants with HepatocellularCarcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resectionor Ablation
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report. In addition, patient should have confirmed disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation.Objectives:
Primary Objectives:1. To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.
Secondary Objectives:
1. To compare overall survival (OS) of nivolumab vs placebo in all randomized participants.
2. To evaluate time to recurrence (TTR) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.
(HCC057)
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or local Ablation (KEYNOTE-937)
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report. In addition, patient should have confirmed disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation.Objectives:
Primary Objectives:1. To compare recurrence-free Survival (RFS).
2. To compare overall survival (OS).
Secondary Objectives:
1. To evaluate the safety and tolerability.
2. To compare time to deterioration (TTD) and score change from baseline in global quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30) global health status/QoL scale and EORTC QLQ-HCC18.
3. To characterize health utilities using the EuroQoL-5 Dimension Questionnaire,5-Level (EQ-5D-5L) healthy utility scores..
(HCC060)
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABELSTUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) PLUS BEVACIZUMAB VERSUS ACTIVESURVEILLANCE AS ADJUVANT THERAPY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA ATHIGH RISK OF RECURRENCE AFTER SURGICAL RESECTION OR ABLATION
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report or have documented evidence of complete radiological response, including disappearance of any intratumoral arterial enhancement in all ablated lesions. In addition, patient should have confirmed disease-free status at least 4 week safter either complete tumor removal after surgical resection or local ablation. Patient is high risk for HCC recurrence after resection or ablation as defined in the protocol.Objectives:
Primary Objectives:1. To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance.
Secondary Objectives:
1. To compare the efficacy of SHR-1210 combined with rivoceranib mesylate versus sorafenib as first-line therapy in subjects with advanced HCC, who have not previously received systemic therapy, through evaluations of PFS, time to progression(TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR)
2. To evaluate the efficacy of atezolizumab plus bevacizumab compared with active
(HCC072)
Sequential TransArterial chemoembolization and stereotactic RadioTherapy Followed by Durvalumab (MEDI4736) and Tremelimumab for downstaging hepatocellular carcinoma for hepatectomy
Chair:
Prof. Stephen Chan
Eligibility:
Adult (≥ 18 years) participants with histologically or radiologically confirmed unresectable HCC. Tumor size 5-25cm and number of lesions <3. Patients should have adequate hepatic and renal function.Objectives:
Primary Objectives:To assess the objective response rate measured by mRECIST criteria in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
Secondary Objectives:
- To assess the number of patients amendable to curative surgical interventions (resection or radiofrequency ablation) after successful down-sizing of tumor(s) by intervention in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To evaluate the time-to-progression (TTP), progression-free survival (PFS) and overall survival (OS) in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To measure the toxicities in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To evaluate the patient-reported quality of life (QoL) treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To describe the pathological response among HCC patients amendable to surgery after receiving combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- Collection of bio-specimens for future correlative studies in patients treated with TACE and SBRT followed by Durvalumab plus Tremelimumab
(HCC073)
A Phase II, Open-Label, Multi-Drug, Multi-Centre, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary) Sub-study 1: Hepatocellular Carcinoma (HCC)
Chair:
Prof. Stephen Chan
Eligibility:
Patient with pathological diagnosis of Hepatocellular Carcinoma who has not received prior systemic therapy. Patient should have at least one measurable lesion and adequate hematologic and hepatic function.Objectives:
Primary Objectives:- Investigator RECIST 1.1-based Assessments
- Objective Response Rate
Secondary Objectives:
- Duration of Response
- Disease Control Rate
- Progression-Free Survival
- Overall Survival
Exploratory Objectives:
- To further assess the efficacy of novel immunomodulators alone or in combination with other anticancer drugs in participants with advanced HCC by evaluation of ORR, DoR, DCR, PFS including PFS9 and PFS12 based on BICR assessment
- To assess the preliminary antitumor activity of novel immunomodulators alone or in combination with other anticancer drugs in participants with advanced HCC
(HCC074)
Epigenetic therapeutics to overcome resistance against immune checkpoint inhibitors in hepatocellular carcinoma: A proof-of-concept clinical trial
Chair:
Prof. Stephen Chan
Eligibility:
Adult (≥ 18 years) participants with radiologically confirmed unresectable HCC. Patient should have received prior treatment with systemic treatment consisting of immune checkpoint inhibitors and no more than two lines of systemic therapy. Patients should have adequate hepatic and renal function.Objectives:
Primary:To study the progression-free survival of patients treated with CXD101 and geptanolimab
Secondary:
- To study secondary efficacy endpoints of patients treated with CXD101 and geptanolimab
- To study the safety of the combination of CXD101 and geptanolimab
- To explore potential biomarkers predictive of benefits of CXD101 and geptanolimab
(HCC077)
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Chair:
Prof. Stephen Chan
Eligibility:
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic participants. Patient should not receive prior systemic treatment for locally advanced or metastatic and/or unresectable HCC. Patients should have adequate hepatic and renal function.Objectives:
Primary:- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
Secondary:
- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To evaluate the safety of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To characterize the PK profile of atezolizumab plus bevacizumab plus tiragolumab
- To evaluate the immune response to tiragolumab and atezolizumab
Exploratory:
- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To evaluate the patient-reported tolerability of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab from the participant's perspective
- To evaluate potential relationships between drug exposure and the efficacy and safety of atezolizumab plus bevacizumab plus tiragolumab
- To evaluate participant demographics, PK, efficacy, and safety endpoints by atezolizumab and tiragolumab ADA status
- To evaluate health status utility scores of participants treated with atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To identify and/or evaluate biomarkers that are predictive of response to atezolizumab plus bevacizumab plus tiragolumab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to atezolizumab plus bevacizumab plus tiragolumab, can provide evidence of atezolizumab plus bevacizumab plus tiragolumab activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics
(HCC078)
Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma with Oligoprogression on Atezolizumab plus Bevacizumab
Chair:
Dr. Landon Chan
Eligibility:
Histologically proven hepatocellular cancer patients who has oligoprogression on Atezolizumab plus Bevacizumab. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To study the progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites.
(LUN107)
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Chair:
Dr. Herbert Loong
Eligibility:
- Adults ≥18 at the time the Main ICF is signed.
- Tumor has PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing.
- Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
- Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
- Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days of randomization.
- Histologically documented NSCLC that meets all of the following criteria:
- Has Stage IIIB or IIIC disease who is not a candidate for surgical resection or definitive chemoradiation, or Stage IV non-squamous NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition26).
- Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue.
- Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies. Subjects with tumors that harbor KRAS mutations are eligible for this study.
- Has an ECOG performance status of 0 or 1 at screening
Objectives:
- To compare the efficacy of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus pemetrexed and platinum-based chemotherapy, as measured by Progression-Free Survival (PFS) by blinded independent central review (BICR), Overall Survival (OS) and objective response rate (ORR).
- To further evaluate the efficacy of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum- pemetrexed chemotherapy
- To evaluate the patient-reported outcomes (PROs) of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum-pemetrexed chemotherapy
- To further evaluate the safety of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum- pemetrexed chemotherapy
- To assess the immunogenicity of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy
(LUN108)
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment naïve Subjects with Advanced or Metastatic PD L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Chair:
Dr. Herbert Loong
Eligibility:
- Adults ≥18 at the time the Main ICF is signed.
- Histologically documented NSCLC that meets all of the following criteria:
- Has Stage IIIB or IIIC disease who is not a candidate for surgical resection or definitive chemoradiation, or Stage IV non-squamous NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition26).
- Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue.
- Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies. Subjects with tumors that harbor KRAS mutations are eligible for this study.
- Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4 micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
- Tumor has high PD-L1 expression (TPS ≥50%) as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides).
- Has measurable disease based on local imaging assessment using RECIST Version 1.1
- Has an ECOG performance status of 0 or 1 at screening
- Has not received prior systemic treatment for advanced or metastatic NSCLC
Objectives:
- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone in terms of either PFS by BICR or OS in treatment-naïve subjects with high PD-L1 expression and advanced or metastatic NSCLC without actionable genomic alterations
- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone in terms of ORR by BICR
(LUN109)
Neoadjuvant Sacituzumab Govitecan plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer: an open-label, multicenter, single arm phase 2 study
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility Criteria:- Stage II to III NSCLC planned for surgical resection
- Absence of EGFR mutation or ALK rearrangement
Objectives:
Study Treatment:- Neoadjuvant Pembrolizumab plus Sacituzumab govitecan followed by surgical resection followed by adjuvant pembrolizumab
(LUN110)
A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer(VELOCITY-Lung) Substudy-01: Patients With No Prior Systemic Treatment for Metastatic Non–Small-Cell Lung Cancer (mNSCLC)
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility Criteria:- Stage IV NSCLC
- Treatment naïve
- Absence of actionable alterations (e.g. EGFR, ALK, ROS1)
Objectives:
Study Treatment:- Novel immunotherapy and chemotherapy combination
(LUN111)
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility Criteria:- Stage IV NSCLC with KRAS G12C mutation
- Prior treatment with immunotherapy and platinum-based chemotherapy
Objectives:
Study Treatment:- Randomize to KRAS G12C inhibitor divarasib or sotorasib
(LUN113)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) who Have not Progressed Following Concurrent Chemoradiation Therapy (DeLLphi-306)
Chair:
Dr. Molly Li
Eligibility:
Male and female subjects (age ≥ 18 years [or legal adult age within country, whichever is older]) with histologically or cytologically confirmed SCLC who have been diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy and have not progressedObjectives:
Hazard ratio (HR) of progression-free survival (PFS) by BICR between tarlatamab and placebo, for subjects with LS-SCLC who have not progressed per investigator assessment of RECIST 1.1 after completion of concurrent chemoradiation therapy consisting of etoposide and platinum (EP), and definitive radiation dose prior to start of new anti-cancer therapy (hypothetical strategy).
(LUN114)
A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-selected non-small-cell lung cancer (GALAXIES LUNG-301)
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility- non small cell lung cancer, stage IV or stage III not amenable to curative resection or concurrent chemoradiotherapy
- no targetable driver mutation
- PD-L1 TPS >= 50%
Objectives:
Subjects to be randomized 1:1 to dorstalimab (anti PD1 antibody) plus belrestotug (anti TIGIT antibody) (study arm) versus pembrolizumab (antiPD1 antibody) (control arm)
(LUN115)
A Phase 1b/2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression
Chair:
Dr. Molly Li
Eligibility:
- Treatment naive stage IV NSCLC
- negative for actionable alterations
- PDL1 TPS >50%
Objectives:
- Novel immunotherapy combinations
(NPC038)
NRG-HN011: A RANDOMIZED PHASE II STUDY OF NIVOLUMAB VERSUS NIVOLUMAB AND BMS-986016 (RELATLIMAB) AS MAINTENANCE TREATMENT AFTER FIRST-LINE TREATMENT WITH PLATINUM-GEMCITABINE-NIVOLUMAB FOR PATIENTS WITH EPSTEIN-BARR VIRUS-ASSOCIATED RECURRENT/METASTATIC NASOPHARYNGEAL CARCINOMA (REMAIN)
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed nasopharyngeal carcinoma with recurrent or metastatic disease. Patient must have adequate hematological, liver and renal function.Objectives:
To determine if adding BMS-986016 (relatlimab) to nivolumab maintenance therapy shows a signal of improved progression-free survival (PFS).
(PST008)
Randomized phase II study of combination androgen deprivation therapy (ADT) and radiotherapy in high risk prostate cancer: Stereotactic body Radiotherapy vs conventionAl IMRT to prostate and pelvic nodes (SRAM study)
Chair:
Dr. Darren Poon
Eligibility:
Patient ≥ 18 years old must have histological confirmation of high risk prostate adenocarcinoma. Patient must not have prior chemotherapy, prostatectomy, cryosurgery or HIFU for prostate cancer.
Objectives:
To compare acute toxicities between SBRT versus conventional IMRT.
(PST012)
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy
Chair:
Dr. Kenneth Wong
Eligibility:
Adult patient must have histologically confirmed Metastatic Castration-resistant Prostate Cancer (mCRPC) with prior treatment. Patient must have adequate hematological, liver and renal function.Objectives:
To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.
(SYM012)
A pilot randomized open-labeled study comparing a structured titration method of immediate- and sustained-release oxycodone versus titration of investigators’ choice inadvanced cancer patients in Hong Kong
Chair:
Dr. Herbert Loong
Eligibility:
Patientmust have moderate to severe cancer pain, able to take oral drugs and withreasonable liver and renal function.Objectives:
To compare efficacy of the structured titrationmethod with predefined titration steps with the use of oxycodoneimmediated-release and oxycodone sustained-release preparations to standard practice.
(TGC001)
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor (MOTION)
Chair:
Dr. Herbert Loong
Eligibility:
Symptomatic patients with histologically confirmed TGCT for whom surgical resection will potentially cause worsening functional limitation or severe morbidity will be eligible. Patients who received anti-CSF1/CSF1R therapy previously (except for imatinib or nilotinib) will be excluded..Inclusion Criteria (PDF):
Exclusion Criteria (PDF):
Objectives:
Primary Objectives:To evaluate anti-tumor activity of vimseltinib using RECIST v1.1 by blinded independent
Secondary Objectives:
• To assess anti-tumor activity of vimseltinib using tumor volume score (TVS) and modified RECIST (mRECIST) by blinded independent radiological review
• To assess the effects of vimseltinib on range of motion (ROM)
• To assess the effects of vimseltinib on physical function, worst stiffness, worst pain, and quality of life (QoL) using patient-reported outcome (PRO) measures
• To assess safety and tolerability of vimseltinib
Exploratory Objectives:
• To assess the correlation of pharmacokinetics (PK) with efficacy and/or safety
• To assess the pharmacodynamic effects of vimseltinib in relation to safety or efficacy
• To assess germline polymorphic variations in genes involved in the metabolism or disposition of vimseltinib or in relation to safety or efficacy.
• To assess long-term safety and efficacy of vimseltinib.
• To assess the effects of vimseltinib on symptomatic relief and functional assessments
(TRA016)
The Immunological Mechanism of Plasma EBV DNA Clearance during Radiotherapy in Patients with Nasopharyngeal Carcinoma-a pilot study
Chair:
Prof. Brigette Ma
Eligibility:
Adult patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma previously untreated and are planned for curative treatment.Objectives:
To investigate changes in T-cell mediated immune response in patients undergoingRT alone or concurrent chemoradiotherapy (CRT) for nasopharyngeal carcinoma(NPC).
(TRA025)
Impact of Radiotherapy on the Dynamic Changes of Circulating Cell-free DNA in Patients with Hepatocellular Carcinoma
Chair:
Dr. Landon Chan