JPRN-jRCT2031200442
Active, not recruiting
Phase 2
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
David Perez Callejo0 sites24 target enrollmentMarch 25, 2021
ConditionsAdvanced Hepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Hepatocellular Carcinoma
- Sponsor
- David Perez Callejo
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 2 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
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 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 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]EUCTR2018-003151-38-CZBristol-Myers Squibb International Corporation357
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