EUCTR2018-003151-38-CZ
Active, not recruiting
Phase 1
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Hepatocellular Carcinoma who are Naive to IO Therapy but Progressed on Tyrosine Kinase Inhibitors
ConditionsAdvanced Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10077738Term: Hepatocellular carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Hepatocellular Carcinoma
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 357
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
- •\- Must have advanced/metastatic HCC
- •\- Have to be immunotherapy treatment\-naive; no prior immunotherapies are permitted
- •\- Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1\.1 measurable untreated lesion
- •\- Child\-Pugh score of 5 or 6
- •\- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 215
Exclusion Criteria
- •\- Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
- •\- Prior organ allograft or allogeneic bone marrow transplantation
- •\- No uncontrolled or significant cardiovascular disease
- •\- No active known autoimmune disease
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Liver Cancer who have never been been Treated with Immuno-oncology Therapy after Prior Treatment with Tyrosine Kinase InhibitorsEUCTR2018-003151-38-PLBristol-Myers Squibb International Corporation250
Recruiting
Phase 1
A Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Liver Cancer who have never been been Treated with Immuno-oncology Therapy after Prior Treatment with Tyrosine Kinase InhibitorsAdvanced Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10077738Term: Hepatocellular carcinoma metastatic Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]CTIS2023-503519-13-00Bristol Myers Squibb International Corporation250
Active, not recruiting
Phase 2
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase InhibitorsAdvanced Hepatocellular CarcinomaJPRN-jRCT2031200442David Perez Callejo24
Active, not recruiting
Phase 1
A Study of Relatlimab-nivolumab Fixed-dose Combination versus Regorafenib or TAS-102 in Participants with Later-lines of Metastatic Colorectal CancerMetastatic Colorectal CancerMedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-004285-35-PLBristol-Myers Squibb International Corporation700
Recruiting
Phase 3
A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal CancerNL-OMON53835Bristol-Myers Squibb24