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

Last updated on May 23, 2019

FOR MORE INFORMATION
Study Location
White Plains Hospital
White Plains, New York, 10601 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03565991
Pfizer
Recruiting
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
NCT03565991
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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