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TerminatedPhase 1 / Phase 2NCT03330405
Official study title

Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Study 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 negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAvelumab Phase 1b and Talazoparib Phase 1b

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 13, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?66 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: Avelumab Phase 1b; Drug: Talazoparib Phase 1b; Drug: Avelumab Phase 2; Drug: Talazoparib Phase 2
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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.
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology GroupFayetteville, Arkansas
  • Highlands OncologyFayetteville, Arkansas
  • Highlands Oncology GroupRogers, Arkansas
  • Highlands OncologyRogers, Arkansas
  • Highlands Oncology GroupSpringdale, Arkansas
  • Highlands OncologySpringdale, Arkansas
  • Tower Hematology Oncology Medical GroupBeverly Hills, California
  • Keck Hospital of USCLos Angeles, California
  • LAC+USC Medical CenterLos Angeles, California
  • USC/Norris Comprehensive Cancer Center/Investigational Drug ServicesLos Angeles, California
  • USC/Norris Comprehensive Cancer CenterLos Angeles, California
  • Cedars-Sinai Medical CenterLos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2023. Always confirm current availability with the study team.

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