Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

Conditions

• Advanced Solid Tumors
• Head and Neck Cancer
• Malignant Glioma
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabiralizumab — BIOLOGICAL
  Solution for IV administration
• Nivolumab — BIOLOGICAL
  Solution for IV administration

Study Details

Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.

Key Dates

Start date

Sep 8, 2015

Status verified

Jan 2022

Primary completion

Nov 18, 2019

Completion

Nov 18, 2019

Study Design

Enrollment

313 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a Monotherapy Dose Escalation
  Cabiralizumab administered at 2 mg/kg every 2 weeks (Q2W), 4 mg/kg Q2W and 6 mg/kg Q2W in participants with any solid tumor.
• Experimental: Phase 1a Combination Therapy Dose Escalation
  Nivolumab 3 mg/kg Q2W + cabiralizumab at the following doses: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 6 mg/kg Q2W. Also nivolumab 3 mg/kg + cabiralizumab 4 mg/kg every 3 weeks (Q3W). Participants with any solid tumor.
• Experimental: Phase 1b Combination Therapy Dose Expansion
  The expansion phase would use the recommended dose determined in Phase 1a: cabiralizumab 4 mg/kg + nivolumab 3 mg/kg Q2W. Participants are enrolled for the following advanced cancer types: non-small cell lung cancer (anti-programmed cell death 1 \[PD1\] targeted drug naïve), non-small cell lung cancer (prior treatment with anti-PD-1), pancreatic cancer, ovarian cancer, renal cell cancer, glioblastoma, and melanoma.

Primary Outcome Measure

Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) [ Time Frame: 28 days ]

Locations (39)

Find similar trials in Scottsdale, AZ

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