Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03294694
Phase
PHASE1
Status
Terminated

Conditions

  • HER2-Negative Breast Cancer
  • Metastatic Epithelial Ovarian Cancer
  • Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Each treatment cycle lasts 28 days. Ribociclib, 1 time per day by mouth for 21 days, followed by 1-week of rest (28-day cycle)
  • PDR001 — DRUG
    Each treatment cycle lasts 28 days. (PDR001) will be administered once every 28 days (by intravenous infusion) over about 30 minutes (or up to 2 hours, if necessary) for the first infusion and over about 30 minutes for all following infusions.
  • Fulvestrant — DRUG
    Each treatment cycle lasts 28 days. Fulvestrant will be administered during Cycle 1 on days 1 and 15, and then on day 1 of each 28-day cycle thereafter.

Study Details

This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone-receptor-positive (HR+), HER2-negative breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer. The names of the medications involved in this study are: * Ribociclib (LEE011) * PDR001 * Fulvestrant

Key Dates

Start date
Nov 8, 2017
Status verified
May 2025
Primary completion
Oct 14, 2020
Completion
Oct 14, 2020

Study Design

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

Arms

  • Experimental: Ribociclib and PDR001 (Cohort A)
    * The treatment regimen is defined as ribociclib + PDR001. * Treatment will be administered on an outpatient basis. * The study will use a 3 + 3 dose escalation design to determine the MTD/RP2D. * Three to six evaluable patients will be enrolled in each cohort in the dose escalation phase. * Once the RP2D of the combination of ribociclib + PDR001 is determined, there will be an expansion cohort. * Cohort A expansion will assess the combination of ribociclib + PDR001 in 12 patients with metastatic ovarian cancer.
  • Experimental: Ribociclib, PDR001 and Fulvestrant (Cohort B)
    * The treatment regimen is defined as ribociclib + PDR001 + fulvestrant . * Treatment will be administered on an outpatient basis. * There will be a safety run-in using the MTD/RP2D of ribociclib + PDR001 from Cohort A with the addition of fulvestrant in an initial 6-12 patients. * Once the safety of the combination of ribociclib + PDR001 + fulvestrant is established, there will be an expansion cohort. * Cohort B expansion will assess the combination of ribociclib + PDR001 + fulvestrant in 24 patients with hormone receptor-positive metastatic breast cancer (HR+ MBC).

Primary Outcome Measure

Cohort A: MTD/RP2D of the Combination of Ribociclib + PDR001 [ Time Frame: 4 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

Related Studies