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Brief Title: Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: CA224-020
  • Secondary ID: N/A
  • NCT ID: NCT01968109
  • Sponsor: Bristol-Myers Squibb

BRIEF SUMMARY

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    November 5, 2013
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of participants with Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Approximately Up to 3 years

Primary Outcome 2 - Measure: Proportion of participants with Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Approximately Up to 3 years

Primary Outcome 3 - Measure: Proportion of Deaths

Primary Outcome 3 - Timeframe: Approximately Up to 3 years

Primary Outcome 4 - Measure: Proportion of participants with laboratory abnormalities in blood

Primary Outcome 4 - Timeframe: Approximately Up to 3 years

Primary Outcome 5 - Measure: Proportion of participants with laboratory abnormalities in blood serum

Primary Outcome 5 - Timeframe: Approximately Up to 3 years

Primary Outcome 6 - Measure: Proportion of participants with laboratory abnormalities in urine

Primary Outcome 6 - Timeframe: Approximately Up to 3 years

Primary Outcome 7 - Measure: Objective response rate (ORR)

Primary Outcome 7 - Timeframe: Approximately 3 years

Primary Outcome 8 - Measure: Disease control rate (DCR)

Primary Outcome 8 - Timeframe: Approximately 3 years

Primary Outcome 9 - Measure: Duration of response (DOR)

Primary Outcome 9 - Timeframe: Approximately 3 years

Primary Outcome 10 - Measure: Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ

Primary Outcome 10 - Timeframe: Approximately 3 years

Primary Outcome 11 - Measure: Proportion of participants with AEs leading to discontinuation of treatment

Primary Outcome 11 - Timeframe: Approximately up to 3 years

CONDITION

  • Neoplasms by Site

ELIGIBILITY

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 participants 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
Other protocol defined inclusion/exclusion criteria could apply

Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact