A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neoplasms by Site

Treatments: Drug: rHuPH20; Biological: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03656718

2018-001585-42 (EudraCT Number)

CA209-8KX

Details and patient eligibility

About

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

• non-small cell lung cancer (NSCLC)
• renal cell carcinoma (RCC)
• unresectable or metastatic melanoma
• hepatocellular carcinoma (HCC)
• microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
• in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
• In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:

  1. Metastatic squamous or non-squamous NSCLC
  2. RCC, advanced or metastatic
  3. Melanoma
  4. HCC
  5. CRC, metastatic (MSI-H or dMMR)
  6. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
  7. In Part E, Metastatic urothelial carcinoma

• Measurable disease as per RECIST version 1.1 criteria

• ECOG performance status of 0 or 1

Exclusion criteria

• Active brain metastases or leptomeningeal metastases
• Ocular melanoma
• Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 7 patient groups

Part A, Group 1: nivolumab (dose 1) + rHuPH20

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Drug: rHuPH20

Part B, Group 3: nivolumab (dose 2) + rHuPH20

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Drug: rHuPH20

Part B, Group 2: nivolumab (dose 1)

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Part B, Group 4: nivolumab (dose 2)

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Part C: nivolumab (dose 3) + rHuPH20

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Drug: rHuPH20

Part D, Group 5: nivolumab (dose 3) + rHuPH20

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Drug: rHuPH20

Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Drug: rHuPH20