NL-OMON48840
Completed
Phase 2
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors - JAVELIN BRCA/ATM
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1\. Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification:
- •\* One or more BRCA1 or BRCA2 gene defect (Cohort 1\);
- •\* ATM gene defect in the absence of concurrent BRCA 1/2 defect (Cohort 2\).
- •Note: in the event that a patient has concomitant defects in more than 1 of the three genes (BRCA1 or BRCA2 or ATM), they will be enrolled in Cohort 1\.
- •The presence of gene defects must have been determined by local assessment and classification using a test of either germline or tumor DNA which was performed in a CAP/CLIA certified (or comparable local or regional certification) laboratory.
- •2\. Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent, as follows:
- •a. Recurrent Epithelial Ovarian Cancer:
- •\* Patients must have received at least 1 but no more than 5 total prior cytotoxic chemotherapy regimens, including at least 1 course of platinum based therapy;
- •\* Patients must not have progressed during or within 1 month after the last dose of the most recent platinum based chemotherapy;
Exclusion Criteria
- •1\. Prior treatment with a PARP inhibitor.;2\. Prior immunotherapy with anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, or anti\-CTLA\-4 antibody.;3\. Prior anti\-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).;4\. Major surgery within 4 weeks prior to study enrollment.;5\. Current use of immunosuppressive medication at the time of study enrollment, EXCEPT for the following permitted steroids: see Section 4\.2\.;6\. Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies (\[NCI CTCAE] v4\.03 Grade \* 3\).;7\. Known history of immune\-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.;8\. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypoor hyperthyroid disease not requiring immunosuppressive treatment are eligible.;9\. Prior organ transplantation including allogenic stem\-cell transplantation.;10\. Administration of live attenuated vaccines within 4 weeks of study enrollment.;11\. Diagnosis of myelodysplastic syndrome (MDS).;12\. Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable.;13\. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation.;14\. Persisting toxicity related to prior therapy (NCI CTCAE v4\.03 Grade \>1\); however, alopecia and sensory neuropathy Grade \* 2, or other Grade \* 2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.;15\. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).;16\. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti\-HCV antibody screening test positive).;17\. Active infection requiring systemic therapy. Minor infections, eg, periodontal or urinary tract infection (UTI) infection, which may be treated with short term oral antibiotics are allowed.;18\. Clinically significant (ie, active) cardiovascular disease: cerebral vascular;accident/stroke (\<6 months prior to study enrollment), myocardial infarction;(\<6 months prior to study enrollment), unstable angina, congestive heart failure (\* New York Heart Association Classification Class II), or a serious cardiac arrhythmia requiring medication.;19\. Current or anticipated use of strong P\-gp inhibitors within 7 days prior to enrollment,or anticipated use during the study. For a list of strong P\-gp inhibitors, refer to Section 5\.7\.10\.;20\. Inability to swallow capsules, known intolerance to talazoparib or its excipients, known malabsorption syndrome, or other condition that may impair absorption of talazoparib.;21\. Bisphosphonate or denosumab dosage that was not stabl
Outcomes
Primary Outcomes
Not specified
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