NCT03565991|TerminatedPhase 2ResultsFDA Drug

Study Stopped

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522)

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 JAVELIN BRCA/ATM

Pfizer ClinicalTrials.gov

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2 other identifiers

B99910322018-000345-39

Study Type

interventional

Target

202

Locations

9 countries

Sites

100

Timeline

RegisteredJun 2018

StartedJun 2018

CompletionFeb 2023

Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

202

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2018

Typical duration for phase_2

Geographic Reach

9 countries

100 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

May 25, 2018

Completed

24 days until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed

6 months until next milestone

Results Posted

Study results publicly available

August 7, 2023

Completed

Last Updated

September 25, 2023

Status Verified

August 1, 2023

Enrollment Period

3.8 years

First QC Date

May 25, 2018

Results QC Date

March 22, 2023

Last Update Submit

August 31, 2023

Conditions

Locally Advanced or Metastatic Solid Tumors Genes, BRCA 1

Keywords

BRCA, ATM

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
For participants with solid tumors, except metastatic Castration Resistant Prostate Cancer (mCRPC), OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-Progressive Disease (PD), where PD was unequivocal progression of pre-existing lesions.
From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months

Secondary Outcomes (24)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately
Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period
From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately
Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period
From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately
Serum Lowest (Trough) Concentration (Ctrough) of Avelumab
Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1
Serum Maximum Concentration (Cmax) for Avelumab
One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1
+19 more secondary outcomes

Study Arms (1)

Combination of avelumab and talazoparib

EXPERIMENTAL

Single arm open label

Drug: AvelumabDrug: Talazoparib

Interventions

AvelumabDRUG

IV treatment

Also known as: Bavencio

Combination of avelumab and talazoparib

TalazoparibDRUG

Oral treatment

Also known as: MDV3800, BMN 673

Combination of avelumab and talazoparib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (100)

Stanford Cancer Center

Palo Alto, California, 94304, United States

Location

Stanford Women's Cancer Center

Palo Alto, California, 94304, United States

Location

Stanford Healthcare

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Atlanta Cancer Care -Alpharetta

Alpharetta, Georgia, 30005, United States

Location

Northside Hospital, Inc. - GCS/Athens

Athens, Georgia, 30606, United States

Location

Northside Hospital, Inc. - GCS/Annex

Atlanta, Georgia, 30341, United States

Location

Atlanta Cancer Care - Atlanta

Atlanta, Georgia, 30342, United States

Location

Northside Hospital, Inc. - Central Research Department

Atlanta, Georgia, 30342, United States

Location

Northside Hospital, Inc. - GCS/Northside

Atlanta, Georgia, 30342, United States

Location

Northside Hospital, Inc. - GCS/Canton

Canton, Georgia, 30114, United States

Location

Atlanta Cancer Care - Cumming

Cumming, Georgia, 30041, United States

Location

Atlanta Cancer Care - Decatur

Decatur, Georgia, 30033, United States

Location

Northside Hospital, Inc.-GCS/Stemmer

Decatur, Georgia, 30033, United States

Location

Atlanta Cancer Care - Stockbridge

Jonesboro, Georgia, 30236, United States

Location

Northside Hospital, Inc.-GCS/Macon

Macon, Georgia, 31217, United States

Location

Northside Hospital, Inc.-GCS/Kennestone

Marietta, Georgia, 30060, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer institute

Boston, Massachusetts, 02215, United States

Location

Siteman Cancer Center - St.Peters

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University Infusion Center Pharmacy

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States

Location

Siteman Cancer Center - North County

St Louis, Missouri, 63136, United States

Location

Memorial Sloan Kettering Cancer Center- Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center- Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone