Status:
TERMINATED
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple ...
Detailed Description
Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction wit...
Eligibility Criteria
Inclusion
- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
- Minimum age in Japan is 20 years.
- ECOG performance status 0 or 1.
- Resolved acute effects of prior therapy
- Adequate bone marrow, renal, and liver function.
- Negative serum pregnancy test at screening.
- Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
- Signed and dated informed consent.
Exclusion
- Prior treatment with a PARP inhibitor.
- Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed
- Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
- Major surgery within 4 weeks prior to study enrollment.
- Current use of immunosuppressive medication at the time of study enrollment.
- Known prior or suspected hypersensitivity to investigational products.
- Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
- Diagnosis of Myelodysplastic Syndrome.
- Patients with known brain metastases requiring steroids.
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
- Persisting toxicity related to prior therapy \>Grade 1
- Known HIV or AIDs-related illness.
- Positive HBV or HCV test indicating acute or chronic infection.
- Active infection requiring systemic therapy.
- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
- Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor.
- Other acute or chronic medical or psychiatric conditions.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT03330405
Start Date
October 19 2017
End Date
January 4 2023
Last Update
October 13 2023
Active Locations (66)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Highlands Oncology
Fayetteville, Arkansas, United States, 72703
3
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
4
Highlands Oncology
Rogers, Arkansas, United States, 72758