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

NCT03012581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2024-02-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Nivolumab

Treatment

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Ligue contre le cancer, France

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Aurélien Marabelle, MD · Gustave Roussy Cancer Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2022-12-22
Completion
2023-11-11

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012581 on ClinicalTrials.gov