A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Conditions

• Colorectal Cancer (CRC)-Enrollment Completed
• Glioblastoma (GBM) (Phase ll Only)-Enrollment Completed
• Ovarian Carcinoma-Enrollment Completed
• Renal Cell Carcinoma (RCC) (Phase ll Only)
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination of varlilumab and nivolumab — DRUG
  Phase I: Varlilumab dosing will be dependent on the cohort assigned in combination with 3 mg/kg of nivolumab every two weeks. Phase II: Patients with CRC, RCC or GBM enrolled in Phase ll will receive 3.0 mg/kg of varlilumab in combination with 240 mg of nivolumab every 2 weeks. Patients with SCCHN or ovarian cancer will receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks, in combination with 240 mg of nivolumab every 2 weeks. Patients may be discontinued from receiving study treatment based on the results of disease assessments or if experiencing intolerable side effects.

Study Details

This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both drugs target the immune system and may act to promote anti-cancer effects.

Key Dates

Start date

Jan 31, 2015

Status verified

Nov 2018

Primary completion

Dec 12, 2018

Completion

Dec 12, 2018

Study Design

Enrollment

175 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Varlilumab and Nivolumab

Primary Outcome Measure

Phase I: Number of participants with treatment-related adverse events as determined by CTCAE v4.0, dose-limiting toxicities, and laboratory abnormalities. [ Time Frame: Safety follow-up is 100 days from last study drug dose. ]

Locations (19)

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