study of subcutaneous nivolumab monotherapy with or without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Phase 1
- Conditions
- The study population will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)renal cell carcinoma (RCC)hepatocellular carcinoma (HCC)unresectable or metastatic melanomaand microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC).MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2018-001585-42-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 130
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) Renal Cell Carcinoma, advanced or metastatic
3) Melanoma
4) Hepatocellular Carcinoma
5) Colorectal Cancer, metastatic (MSI-H or dMMR)
- Measurable disease as per RECIST version 1.1 criteria
- ECOG performance status of 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
Exclusion Criteria
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Active, known, or suspected autoimmune disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the pharmacokinetics of nivolumab administered subcutaneously, with or without rHuPH20;Secondary Objective: - To assess the safety profile of SC nivolumab<br>- To evaluate incidence of AEs in the broad scope MedDRA Anaphylactic Reaction SMQ and the select AE hypersensitivity/infusion reaction category<br>- To assess the immunogenicity of nivolumab;Primary end point(s): Serum nivolumab:<br>-Cmax (Maximal concentration)<br>-Tmax (Time to maximal concentration)<br>-AUC(TAU) (Area under the concentration-time curve in one dosing interval)<br>-Ctau (observed serum nivolumab concentration at the end of the dosing interval);Timepoint(s) of evaluation of this end point: For all primary endpoints: approximately 1 year after Last Patient First Treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities<br>- Incidence of AEs in the MedDRA Anaphylactic Reaction broad scope SMQ occurring within 2 days after study drug administration<br>- Incidence of events within the hypersensitivity/infusion reaction select AE category occurring within 2 days after any study drug administration.<br>- Incidence of anti-nivolumab antibodies and neutralizing antibodies, if applicable;Timepoint(s) of evaluation of this end point: For all secondary endpoints: approximately 2 years after Last Patient First Treatment