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CompletedLast updated: 29 January 2024

This phase I trial is combining two anti-cancer drugs (Rucaparib and Atezolizumab) in patients with advanced cancers of the female reproductive system, ovarian cancer in particularA Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants With Solid Tumors and Advanced Gynecologic Cancers, With a Focus on Ovarian Cancer

Clinical summary

Summary

This is a Phase Ib, open-label, non-randomized study in participants with advanced gynecological cancers (Part 1) and platinum-sensitive ovarian cancer (Part 2) to investigate the dose, safety, pharmacokinetics, and efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2).

Conditions

This trial is treating patients with cancers of the female reproductive system, ovarian cancer in particular.

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants With Solid Tumors and Advanced Gynecologic Cancers, With a Focus on Ovarian Cancer

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • A life expectancy of at least 3 months
  • Have disease that is measurable as according to RECIST v1.1
  • Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
  • For Part 1, have a histologically confirmed diagnosis of ovarian or endometrial cancer, and have received at least one line of prior therapy for metastatic disease
  • For Part 2 ONLY, have disease that can be safely biopsied
  • For Part 2 ONLY, have a deleterious germline or somatic breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation or tumors that are wild-type BRCA but show high levels of loss of heterozygosity (LOH) (tBRCAwt/LOHhigh) signature
  • For Part 2 Cohort 1 (ovarian cancer), high-grade serous or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (PPC)
  • For Part 2 Cohort 1, have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe
  • For Part 2 ONLY, Cohort 1, have a CA125 measurement that is greater than 2 times the upper limit of normal (ULN)
  • For Part 2 Cohort 2 (TNBC), metastatic, histologically confirmed estrogen receptor (ER)-negative, progesterone receptor-negative, and HER2-negative adenocarcinoma of the breast per local laboratory assessment
  • For Part 2 Cohort 2, radiologic/objective evidence of recurrence or disease progression after one line of chemotherapy for TNBC in the metastatic setting
  • Have adequate organ function

Exclusion

  • History of prior malignancy except a) curatively treated non-melanoma skin cancer, b) solid tumor treated curatively more than 3 years ago without evidence of recurrence, c) For Cohort 1 (ovarian cancer): breast cancer with no evidence of disease or inactive for at least 3 years, and d) synchronous endometrial cancer (Stage 1A) with ovarian cancer
  • Treatment with chemotherapy, radiation, hormones (except corticosteroids and megestrol acetate), or other anticancer therapies less than or equal to (<=) 14 days prior to first dose of study treatment
  • Preexisting duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib
  • Symptomatic and/or untreated central nervous system metastases
  • Prior treatment with any poly adenosine diphosphate-ribose polymerase (PARP) inhibitor

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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