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Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

NCT03565991

TerminatedPhase 2

Sponsor: Pfizer

Conditions: Locally Advanced or Metastatic Solid Tumors, Genes, BRCA 1

Interventions: Avelumab, Talazoparib

Countries: United States, Belgium, Denmark, France, Italy, Japan, Netherlands, Spain

Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* BRCA1, BRCA2 and/or ATM gene defect.
* Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent
* Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.
* Progressive disease at study enrollment.
* Minimum age 18 years (in Japan, minimum age 20 years).
* ECOG performance status 0 or 1.
* Adequate bone marrow, renal and liver function.
* For childbearing female patients, negative serum or urine pregnancy test at screening
* Signed and dated informed consent document.

Exclusion Criteria:

* Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
* Major surgery within 4 weeks prior to study enrollment.
* Current use of immunosuppressive medication at the time of study enrollment.
* Known prior severe hypersensitivity to investigational products or any component in their formulations
* 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.
* Administration of live attenuated vaccines within 4 weeks of study enrollment.
* Diagnosis of myelodysplastic syndrome.
* Known symptomatic brain metastases requiring steroids.
* Persisting toxicity related to prior therapy Grade \>1.
* Known history of HIV or AIDS.
* Positive HBV or HCV test indicating acute or chronic infection.
* Active infection requiring systemic therapy.
* Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
* Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers.
* Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.
Locations (100)
  • Palo Alto, California, United States
  • Palo Alto, California, United States
  • Stanford, California, United States
  • Stanford, California, United States
  • Alpharetta, Georgia, United States
  • Athens, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Canton, Georgia, United States
  • Cumming, Georgia, United States
  • Decatur, Georgia, United States
  • Decatur, Georgia, United States
  • Jonesboro, Georgia, United States
  • Macon, Georgia, United States
  • Marietta, Georgia, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • City of Saint Peters, Missouri, United States
  • Creve Coeur, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Middletown, New Jersey, United States
  • Harrison, New York, United States
  • Long Island City, New York, United States
  • + 70 more on CT.gov