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A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types - CA209-76U

Updated: 26 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 17


  • Recruiting

Treatment Options

Study Arms
Experimental: Part 1 Arm A: mM, mUC, HCC
Experimental: Part 1: Arm B: mM
Drug: nivolumab Drug: ipilimumab
Experimental: Part 2: Arm A: NSCLC
Drug: ipilimumab Drug: nivolumab Drug: ENHANZE (rHuPH20)
Experimental: Part 2: Arm B: RCC
Drug: ipilimumab Drug: nivolumab Drug: ENHANZE (rHuPH20)

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Men and women must follow methods of contraception as described in the protocol Part 1 Arms A and B: Metastatic Melanoma - Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0 Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma. Part 1 Arm A: Advanced HCC - Participants with histological confirmation of Hepatocellular Cancer (HCC) Part 2 Arm A: Metastatic NSCLC - Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC) Part 2 Arm B: Advanced or Metastatic RCC - Histological confirmation of Renal Cell Carcinoma (RCC) - ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70% Exclusion Criteria: - History of allergy or hypersensitivity to study drug components Part 1 Arm A: Advanced HCC - History of hepatic encephalopathy or evidence of portal hypertension - Active coinfection with hepatitis D virus infection in participants with HBV Part 2 Arm A:Metastatic NSCLC - Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy Other inclusion/exclusion criteria apply.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com