Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Sponsor
UNICANCER
Study ID
NCT03012581
Phase
PHASE2
Status
Completed

Conditions

  • Cancer With POLE Exonucleasic Domain Mutation
  • Carcinoma, Renal Cell
  • Head and Neck Neoplasm
  • Microsatellite Instability
  • Penile Neoplasms
  • Skin Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available.

Key Dates

Start date
Jun 16, 2017
Status verified
Feb 2024
Primary completion
Dec 22, 2022
Completion
Nov 11, 2023

Study Design

Enrollment
269 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab 240 mg IV over 60 minutes every 14 days.

Primary Outcome Measure

Objective response rate [ Time Frame: measured at the first scheduled disease assessment following study treatment initiation (Day 84, ± 7 days) ]

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