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)

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02553642
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 14, 2015
Status verified
Jul 2025
Primary completion
Apr 29, 2024
Completion
Apr 29, 2024

Study Design

Enrollment
81 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Melanoma Cancer Patients
    All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
  • Experimental: Bladder Cancer Patients
    All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.

Primary Outcome Measure

Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy [ Time Frame: From treatment start, up to 2 years from initial dose of nivolumab. ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Connecticut Health CenterFarmingtonConnecticut06030-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Lehigh Valley Health NetworkAllentownPennsylvania18103-

Related coverage on Hipa.ai

Find similar trials in Farmington, CT

By condition
Bladder cancerMelanoma
By specialty
OncologyUrologySkin cancerDermatology
By research site
University of Connecticut Health Center· Farmington, CTMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYLehigh Valley Health Network· Allentown, PA

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