A phase 2 study of pembrolizumab in combination with olaparib in patients with recurrent or metastatic cervical cancer who had disease progression during or after platinum-based chemotherapy - GOTIC-025

Hasegawa Kosei0 sites28 target enrollmentMay 18, 2021

Conditionsrecurrent or metastatic cervical cancer cervical cancer ,Pembrolizumab,Olaparib

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: recurrent or metastatic cervical cancer
Sponsor: Hasegawa Kosei
Enrollment: 28
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 18, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Hasegawa Kosei

Eligibility Criteria

Inclusion Criteria

•1\.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)
•2\.Participants with confirmed disease progression during or after platinum\-based chemotherapy or intolerant to or ineligible for platinum\-based chemotherapy or ineligible participants
•3\.Participants with measurable disease based on RECIST 1\.1 at screening
•4\.Participant is able to provide a core or excisional biopsy of a tumor lesion for testing of PD\-L1 status, etc
•5\.Participants with Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 upon the screening
•6\.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
•7\.Have adequate organ function

Exclusion Criteria

•1\.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\).
•2\.Has received prior systemic anti\-cancer therapy including investigational agents within 4 weeks prior to the enrollment.
•3\.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.
•4\.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\-Guerin (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.
•5\.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.
•6\.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.
•7\.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).
•8\.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.
•9\.Has severe hypersensitivity (\>\=Grade 3\) to the study drug and/or any of its excipients.
•10\.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.