Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03326258
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Advanced Malignant Solid Neoplasm
  • Estrogen Receptor Negative
  • GPNMB Positive
  • HER2/Neu Negative
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Progesterone Receptor Negative
  • Stage III Breast Cancer AJCC v7
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage III Uveal Melanoma AJCC v7
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Uveal Melanoma AJCC v7
  • Triple-Negative Breast Carcinoma
  • Unresectable Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Glembatumumab Vedotin — DRUG
    Given IV
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as glembatumumab vedotin, nivolumab, and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Apr 20, 2018
Status verified
May 2018
Primary completion
Apr 20, 2018
Completion
Apr 20, 2018

Study Design

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

Arms

  • Experimental: Treatment (glembatumumab vedotin, nivolumab, ipilimumab)
    Patients receive glembatumumab vedotin IV over 90 minutes and nivolumab IV over 60 minutes on day 8 of course 1 and on day 1 of subsequent courses. Patients in melanoma expanded cohort also receive ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 21 days for 4 courses in the absence of disease progression or unaccepted toxicity and courses with glembatumumab vedotin and nivolumab repeat every 21 days in the absence of disease progression or unaccepted toxicity.

Primary Outcome Measure

Recommended phase 2 dose for the combination of glembatumumab vedotin and nivolumab (Phase Ib) [ Time Frame: Up to 21 days ]

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