The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | October 14, 2013 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Proportion of subjects with Adverse Events (AEs)
Primary Outcome 1 - Time Frame: Approximately Up to 3 years
Primary Outcome 2 - Measure: Proportion of subjects with Serious Adverse Events (SAEs)
Primary Outcome 2 - Time Frame: Approximately Up to 3 years
Primary Outcome 3 - Measure: Proportion of Deaths
Primary Outcome 3 - Time Frame: Approximately Up to 3 years
Primary Outcome 4 - Measure: Proportion of subjects with laboratory abnormalities
Primary Outcome 4 - Time Frame: Approximately Up to 3 years
Primary Outcome 5 - Measure: Objective response rate (ORR)
Primary Outcome 5 - Time Frame: Approximately 3 years
Primary Outcome 6 - Measure: Disease control rate (DCR)
Primary Outcome 6 - Time Frame: Approximately 3 years
Primary Outcome 7 - Measure: Duration of response (DOR)
Primary Outcome 7 - Time Frame: Approximately 3 years
Primary Outcome 8 - Measure: Proportion of participants with AEs meeting acute safety criteria
Primary Outcome 8 - Time Frame: Approximately 3 years
Primary Outcome 9 - Measure: Proportion of subjects with AEs leading to discontinuation of treatment
Primary Outcome 9 - Time Frame: Approximately up to 3 years
Criteria:
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion Criteria:
- For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer
(CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology
agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to
IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma
subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or
without anti-CTLA-4.
- For Dose Expansion: all of the above in escalation except for cervical, ovarian, and
CRC
- Progressed, or been intolerant to, at least one standard treatment regimen, except for
subjects in 1st line cohorts.
- ECOG performance status between 0 and 2
- At least 1 lesion with measurable disease at baseline
- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment
tumor biopsy)
Exclusion Criteria:
- Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the
only site of active disease
- Autoimmune disease
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent
- Uncontrolled CNS metastases
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Gender: All
Minimum Age: 12 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Bristol-Myers Squibb
Role: Study Director
Affiliation: Bristol-Myers Squibb
Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Phone:
Email: Clinical.Trials@bms.com
Link: BMS Clinical Trial Information
