Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Uterine Cervical Neoplasms

Anemia

Fanconi Syndrome

Fanconi Anemia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Congenital Aplastic Anemia

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib

PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks

pembrolizumab

PARP inhibitor olaparib 300 mg orally, twice daily (BID)

olaparib

John P. Diaz, MD

The study is a non-randomized, open-label phase II clinical trial to test the investigational combination of the drug pembrolizumab with the drug olaparib in patients diagnosed with advanced or recurrent cervical carcinoma after standard chemotherapy.

Cervical cancer is a disease of the female genital tract. No male patients will be enrolled.

Pembrolizumab and Olaparib in Cervical Cancer Patients

Immunotherapy in Combination With PARP Inhibition in Advanced Cervical Cancer Patients Functionally Competent or Deficient for the Fanconi Anemia Repair Pathway

Overall objective Response Rate by Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria (iORR)

Defined among all treated patients as the time from first dose of study drug until the first date of either disease progression or death due to any cause

The number of patients reporting treatment emergent adverse events (TEAEs) defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study

The number of patients with baseline tumor deficiencies in the Fanconi Anemia pathway associated with antitumor responses to the combination as assessed by the Fanconi Anemia Triple Stain Immunofluorescence assay, performed on archived paraffin embedded tumor tissues.

Duration of response (DoR), defined as time from documentation of tumor response to disease progression

Florida Department of Health

Merck Sharp & Dohme LLC

John Diaz

Chief of Gynecologic Oncology, Director of Robotic Surgery

Spots Global Cancer Trial Database for Pembrolizumab and Olaparib in Cervical Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial