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

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

This Phase 1b/2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different study drugs can be given together safely and which doses to use for further research. Phase 2 will test if the study treatments have an effect on tumor size and growth, and gather more information about potential side effects.

Key facts

Study ID

NCT03637491

Run by

Pfizer

People needed

36

Starts

2018-08-15

Expected to finish

2021-02-02

Last updated by the study team

2022-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent as follows:
• Metastatic pancreatic ductal adenocarcinoma; or
• Phase 2 only: Stage IIIb/IV NSCLC or 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.

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• California Cancer Associates for Research and Excellence, Inc (cCARE) — Encinitas, California, United States
• University of Colorado Denver CTO (CTRC) — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Horizon Oncology Research, LLC — Lafayette, Indiana, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Institut Jules Bordet — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• Singapore National Eye Centre — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• SingHealth Investigational Medicine Unit — Singapore, Singapore
• National Heart Centre Singapore — Singapore, Singapore
• National Cancer Centre Singapore — Singapore, Singapore

Full record on ClinicalTrials.gov

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