Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

NCT04641728 | Unknown Phase 2 FDA Drug

• 1 other identifier: GOTIC-025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy.

Conditions

Cervical Cancer

Keywords

cervical cancer; pembrolizumab; olaparib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective Response Rate (ORR) will be evaluated after pembrolizumab in combination with olaparib based on RECIST 1.1.

  3 years

Secondary Outcomes (10)

• Objective Response Rate on iRECIST

  3 years

• Duration of response

  3 years

• Durable response rate

  3 years

• Percentage of patients with response to administration of pembrolizumab in combination with olaparib for 6 months and longer

  3 years

• PFS after administration of pembrolizumab in combination with olaparib

  3 years

Other Outcomes (1)

• Overall survival after administration of pembrolizumab in combination with olaparib based on RECIST 1.1

  3 years

Study Arms (1)

pembrolizumab plus olaparib

EXPERIMENTAL

Until RECIST-based confirmation of progressive disease (PD), death, manifestation of intolerable toxicity, or participant withdrawal from the study, study participants will continue intravenous infusion of pembrolizumab 200 mg every three weeks (Q3W) in combination with oral olaparib 300 mg twice daily (BID) (combination therapy)

Drug: Pembrolizumab; Drug: Olaparib

Interventions

Pembrolizumab DRUG

pembrolizumab 200 mg every three weeks (Q3W)

Also known as: KEYTRUDA

pembrolizumab plus olaparib

Olaparib DRUG

olaparib 300 mg twice daily (BID)

Also known as: LYNPARZA

pembrolizumab plus olaparib

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed, recurrent or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma)
• Participants with confirmed disease progression during or after platinum-based chemotherapy 1 or intolerant to or ineligible for platinum-based chemotherapy or ineligible participants
• Participants with measurable disease based on RECIST 1.1 at screening
• Participant is able to provide a core or excisional biopsy of a tumor lesion for testing of PD-L1 status, etc
• Participants with Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 upon the screening
• Participants who may be expected to survive at least for 12 weeks after the first dose of study drug as determined by the principal investigator or a subinvestigator
• Have adequate organ function

You may not qualify if:

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the enrollment.
• Has received prior radiotherapy within 2 weeks prior to the enrollment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
• Has received a live vaccine within 28 days prior to the enrollment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the enrollment.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
• Has a second malignancy advanced or requiring treatment within the past 3 years.The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, in situ cancers (e.g. in situ breast carcinomas).
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the enrollment.
• Has severe hypersensitivity (≥Grade 3) to the study drug and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and participants can be enrolled in the trial.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of Human Immunodeficiency Virus (HIV) infection.
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
• Has a known history of active TB (Bacillus Tuberculosis).

Sponsors & Collaborators

• Saitama Medical University International Medical Center: lead
• Tokyo University: collaborator
• National Cancer Center, Japan: collaborator
• Cancer Institute Hospital, Japan: collaborator
• Aichi Cancer Center: collaborator

Study Sites (1)

Saitama Medical Uiversity International Medical Center

Hidaka, Saitama, 3501298, Japan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

pembrolizumab; olaparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kosei Hasegawa, MD, PhD

  Saitama Medical University International Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 24, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)