A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Completed · Phase 2

Conditions studied: Pan Tumor

In brief

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

Key facts

Study ID

NCT03668119

Run by

Bristol-Myers Squibb

People needed

212

Starts

2018-10-31

Expected to finish

2023-08-02

Last updated by the study team

2024-08-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
• Must be able to provide tissue and blood TMB-H testing results
• Must have measurable disease for response assessment

You may not qualify if…

• Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
• Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
• Other protocol defined inclusion/exclusion criteria apply.

Where it is running

• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Local Institution - 0093 — Minneapolis, Minnesota, United States
• Broome Oncology — Johnson City, New York, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Local Institution - 0079 — Portland, Oregon, United States
• Local Institution - 0095 — Austin, Texas, United States
• Local Institution - 0094 — Dallas, Texas, United States
• Local Institution - 0090 — Houston, Texas, United States
• Texas Oncology - Northeast Texas — Tyler, Texas, United States
• Local Institution - 0016 — Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
• Local Institution - 0087 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0078 — CABA, Argentina
• Local Institution - 0015 — CABA, Argentina
• Local Institution - 0119 — Córdoba, Argentina
• Local Institution - 0118 — St Leonards, New South Wales, Australia
• Local Institution - 0062 — Sydney, New South Wales, Australia
• Local Institution - 0117 — Woolloongabba, Queensland, Australia
• Local Institution - 0112 — Brussels, Belgium
• Local Institution - 0113 — Brussels, Belgium
• Local Institution - 0114 — Leuven, Belgium
• Local Institution - 0010 — Edmonton, Alberta, Canada
• Local Institution - 0060 — Hamilton, Ontario, Canada
• Local Institution - 0036 — Montreal, Quebec, Canada
• Local Institution - 0088 — Montreal, Quebec, Canada
• John Wayne Cancer Center — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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