Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy

Phase 2

Recruiting

Conditions: colorectal cancer (MSI-H/dMMR)
non-small cell lung cancer
renal cell carcinoma
Metastatic melanoma
10027655

Registration Number: NL-OMON55364

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

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
- Prior radiotherapy must have been completed at least 2 weeks prior to study
treatment administration.
- Screening laboratory values must meet protocol criteria
- Abdominal skin must be free from any disease, condition or skin pigmentation
- Participants should not have received any systemic anticancer therapy after
the date that the submitted tumour tissue was obtained
- Patient must have suitable tumour tissue available as per protocol
requirements.

Exclusion Criteria

- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Active, known, or suspected autoimmune disease
- Condition requiring systemic treatment with corticosteroids or other
immunosuppresive medications
- Prior malignancy active within the previous 2 years
- Prior treatment with antibodies or drugs specifically targeting T-cell
co-stimulation or checkpoint pathways
- Known history of HIV or AIDS
- Positive pregnancy test
- Breastfeeding
- Vaccines containing live/attenuated virus within 30 days prior to start of
the study
- LVEF < 50%
- Positive test result for HBV or HCV

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective of the study is to describe the pharmacokinetics (PK) of<br /><br>nivolumab administered subcutaneously, with or without rHuPH20.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives of the study as to assess safety profile of SC Nivolumab<br /><br>by measuring the incidence of AEs, SAEs, AEs leading to discontinuation, deaths<br /><br>and lab abnormalities. This study will also evaluate incidence of AEs in the<br /><br>broad scope MedDRA Anaphylactic Reaction SMQ and the select AE<br /><br>hypersensitivity/infusion reaction category, by analysis of those AEs occurring<br /><br>within 2 days after study drug administration.<br /><br>Another secondary objective is to assess the immunogenicity of Nivolumab by<br /><br>reviewing the incidence of antinivolumab<br /><br>antibodies and neutralizing antibodies (if applicable).</p><br>