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

Last updated on October 17, 2018

FOR MORE INFORMATION
Study Location
Stanford Women's Cancer Center
Palo Alto, California, 94304 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.
Show details

- 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 female patients; breastfeeding female patients; fertile male patients and
female patients of childbearing potential who are unwilling or unable to use 2 methods
of contraception.

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

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Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
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
Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.

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 with programmed death receptor 1 (PD-1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors with a BReast CAncer susceptibility gene (BRCA)1, or BRCA2, or ataxia telangiectasia mutated (ATM) gene defect.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Intervention Model Description:

Single arm study with two cohorts enrolled in parallel.

  • Cohort 1 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes
  • Cohort 2 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the ATM gene

Masking: None (Open Label)
Masking Description:

Open label

Primary Purpose: Treatment

  • Locally Advanced or Metastatic Solid Tumors
  • Genes, BRCA 1
  • Drug: Avelumab
    IV treatment
    Other Name: Bavencio
  • Drug: Talazoparib
    Oral treatment
    Other Name: MDV3800, BMN 673
Experimental: Combination of avelumab and talazoparib
Single arm open label
Interventions:
  • Drug: Avelumab
  • Drug: Talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
Same as current
December 2, 2022
March 8, 2021   (Final data collection date for primary outcome measure)

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 female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 methods of contraception.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03565991
B9991032
2018-000345-39 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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