Pembrolizumab and olaparib in recurrent/metastatic, platinum resistant nasopharyngeal cancer - POINT

Fondazione GONO0 sites30 target enrollmentOctober 5, 2021

Conditionsasopharyngeal cancer MedDRA version: 21.0Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA (pembrolizumab, MK3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: asopharyngeal cancer
Sponsor: Fondazione GONO
Enrollment: 30
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 5, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fondazione GONO

Eligibility Criteria

Inclusion Criteria

•1\.Male/female participants who are at least 18 years old
•2\.The participant (or legally acceptable representative) provides written informed consent.
•3\.Histologically confirmed diagnosis of nasopharyngeal carcinoma.
•4\.Disease not amenable of surgical resection or irradiation with curative intent.
•5\.Disease progressing within 6 months since previous platinum\-based systemic treatment (as concomitant to RT or as first line treatment for RM NPC).
•6\.Male participants:
•A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.
•Female participants:
•A female participant is eligible to participate if she is not pregnant (see Appendix 3\), not breastfeeding, and at least one of the following conditions applies:
•oNot a woman of childbearing potential (WOCBP) as defined in Appendix 3

Exclusion Criteria

•1\.WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3\). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•2\.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 (e.g., CTLA\-4, OX\-40, CD137\).
•3\.Prior systemic anti\-cancer therapy including investigational agents within 4 weeks prior to allocation.
•4\.Prior radiotherapy within 2 weeks of study intervention start. 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.
•5\.Received a live vaccine or live\-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
•7\.Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•8\.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
•9\.Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided those 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 first dose of study intervention.
•11\.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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
•18\.Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.