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Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)

NCT02553642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-07-22

Study results available
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Summary

The purpose of this study is to investigate the characteristics of tumors in patients treated with nivolumab and to identify features that help to predict a good or bad response to this drug.

Conditions

Interventions

DRUG

Nivolumab

Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks OR \- Nivolumab 480 mg flat dose Dosed q 4 weeks for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit

DRUG

Nivolumab plus Ipilimumab

Combination Treatment * Ipilimumab 3 mg/kg * Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses

Sponsors & Collaborators

Principal Investigators

  • Samuel Funt, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-14
Primary Completion
2024-04-29
Completion
2024-04-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02553642 on ClinicalTrials.gov