A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04931342
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ipatasertib — DRUG
    Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
  • Cobimetinib — DRUG
    Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
  • Trastuzumab Emtansine — DRUG
    Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
  • Paclitaxel — DRUG
    Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
  • Giredestrant — DRUG
    Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
  • Abemaciclib — DRUG
    Abemaciclib will be administered by mouth twice a day during each 28-day cycle
  • Inavolisib — DRUG
    Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
  • Palbociclib — DRUG
    Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
  • Letrozole — DRUG
    Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
  • Olaparib — DRUG
    Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
  • Luteinizing Hormone-Releasing Hormone (LHRH) Agonists — DRUG
    LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)
  • Inavolisib — DRUG
    Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

Study Details

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Key Dates

Start date
Oct 7, 2021
Status verified
Jun 2026
Primary completion
Feb 28, 2028
Completion
May 30, 2028

Study Design

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

Arms

  • Experimental: Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)
    Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)
    Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)
    Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Atezolizumab + Bevacizumab (Non-matched)
    Participants in the Atezolizumab + Bevacizumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
  • Experimental: Giredestrant + Abemaciclib (ER+ tumors)
    Participants in the Giredestrant + Abemaciclib arm will receive treatment until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
  • Experimental: Inavolisib + Palbociclib (PIK3CA-altered tumors)
    Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)
    Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Inavolisib + Olaparib (Non-matched)
    Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)
    Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Inavolisib + Bevacizumab (PIK3CA-altered tumors)
    Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
  • Experimental: Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)
    Participants in the Atezolizumab + Bevacizumab + Cyclophosphamide arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family CCCSan FranciscoCalifornia94158-
Washington University School of MedicineSt LouisMissouri63108-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Ohio State UniversityColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Texas Oncology - Gulf CoastThe WoodlandsTexas77380-
Virginia Oncology AssociatesNorfolkVirginia23502-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in San Francisco, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UCSF Helen Diller Family CCC· San Francisco, CAWashington University School of Medicine· St Louis, MOLevine Cancer Institute· Charlotte, NCOhio State University· Columbus, OHUniversity of Oklahoma Health Sciences Center· Oklahoma City, OKTexas Oncology - Gulf Coast· The Woodlands, TX

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