Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Parker Institute for Cancer Immunotherapy
Study ID
NCT03651271
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Metastatic Cancer
  • Advanced Prostate Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab Monotherapy — BIOLOGICAL
    Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
  • Nivolumab and Ipilimumab and Combination for Metastatic Cancer — BIOLOGICAL
    For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
  • Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer — BIOLOGICAL
    For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
  • Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer — BIOLOGICAL
    For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.

Study Details

This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive nivolumab monotherapy, and participants who have a tumor with \< 15% CD8 cells (classified as CD8 low) will receive ipilimumab in combination with nivolumab.

Key Dates

Start date
Oct 17, 2018
Status verified
Jan 2024
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "Hot" tumors for Advanced Metastatic Cancer
    Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
  • Experimental: "Cold" tumors for Advanced Metastatic Cancer
    Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
  • Experimental: "Hot" tumors for Advanced Prostate Cancer
    Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
  • Experimental: "Cold" tumors for Advanced Prostate Cancer Cohort A
    Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
  • Experimental: "Cold" tumors for Advanced Prostate Cancer Cohort B
    Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.

Primary Outcome Measure

Clinical Benefit Rate (CBR) of Nivolumab With or Without Ipilimumab [ Time Frame: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
Stanford UniversityPalo AltoCalifornia94304-
University of California, San FranciscoSan FranciscoCalifornia94143-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAStanford University· Palo Alto, CAUniversity of California, San Francisco· San Francisco, CADana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYM.D. Anderson Cancer Center· Houston, TX

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