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A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

Last updated on June 7, 2019

FOR MORE INFORMATION
Study Location
Institut Jules Bordet
Brussels, , 1000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Cancer, Non-Small Cell Lung Cancer, Cancer
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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- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent as follows:

1. Stage IIIb/IV NSCLC with documented positive KRAS or NRAS mutation status as
determined using a validated test performed in a College of American Pathologists
(CAP)/Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (or
other comparable local or regional certification); or

2. Metastatic pancreatic ductal adenocarcinoma; or

3. Phase 2 only: other advanced solid tumors with documented positive KRAS or NRAS
mutation as determined using a validated test performed in a CAP/CLIA-certified
laboratory (or other comparable local or regional certification).

- Have had disease progression during or following at least 1 and not more than 2 prior
lines of treatment for advanced or metastatic disease.

- Patients with NSCLC must have previously received treatment with an anti-PD-1 or
anti-PD-L1 agent for advanced disease.

- Measurable disease as per RECIST v1.1 criteria.

- Provision of a baseline tumor sample.

- Age ≥18 years (Japanese patients must be ≥20 years old)

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

- Adequate bone marrow, renal and liver functions.

- Adequate cardiac function.

- Informed consent provided.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with avelumab, a PARP inhibitor or MEK inhibitor.

- Prior systemic anti-cancer therapy within 2 weeks prior to study enrollment.

- Persisting toxicity related to prior therapy.

- Current use of immunosuppressive medication.

- Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis, uveitis or iritis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Diagnosis of myelodysplastic syndrome (MDS).

- Known symptomatic brain metastases requiring steroids.

- Known history of testing positive for HIV or hepatitis.

- Clinically significant (ie, active) cardiovascular disease.

- History of thromboembolic or cerebrovascular events.

- Current or anticipated use of a P-gp inhibitor, inducer, or inhibitor of breast cancer
resistance protein (BCRP)

- Uncontrolled hypertension.

- Concurrent neuromuscular disorder that is associated with the potential of elevated
creatinine kinase.

- Known history of Gilbert's syndrome.

- History or current evidence of retinal degenerative disease, retinal vein occlusion
(RVO) or current risk factors for RVO.

- Other acute or chronic medical or psychiatric condition.

NCT03637491
Pfizer
Recruiting
A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

NEED INFO?

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]

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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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