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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 August 24, 2018

FOR MORE INFORMATION
Study Location
Highlands Oncology Group
Fayetteville, Arkansas, 72703 United States
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.
Show details

- 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
Not yet recruiting
A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

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A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors
A Phase 1b/2 Study To Evaluate Safety And Clinical Activity Of Avelumab In Combination With Binimetinib With Or Without Talazoparib In Patients With Locally Advanced Or Metastatic Ras-mutant Solid Tumors
This Phase 1b/2 study will examine the effects of the study drugs, avelumab and binimetinib given together (doublet) and in combination with talazoparib (triplet), 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.

This is a Phase 1b/2, open label, multi-center, safety, clinical activity, pharmacokinetic (PK), and pharmacodynamics (PD) study of avelumab in combination with binimetinib with or without talazoparib in adult patients with locally advanced or metastatic KRAS- or NRAS-mutant non-small cell lung cancer, pancreatic ductal adenocarcinoma, or other KRAS- or NRAS-mutant solid tumors.

The Phase 1b part of this study will initially assess the combination of avelumab and binimetinib (doublet) to determine a recommended dose for further investigation. Following this, the recommended dose for the combination of avelumab, binimetinib and talazoparib (triplet) will be determined. The recommended doses for the doublet and triplet combinations will be used in the Phase 2 part of the study, which will assess the safety and preliminary anti-tumor activity of the study treatments.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Non-Small Cell Lung Cancer
  • Cancer
  • Drug: Avelumab
    IV treatment
    Other Name: MSB0010718C
  • Drug: Binimetinib
    Oral treatment
    Other Names:
    • MEK162
    • ARRY-438162
  • Drug: Talazoparib
    Oral treatment
    Other Name: MDV3800, BMN 673
  • Experimental: Avelumab and binimetinib
    Open label
    Interventions:
    • Drug: Avelumab
    • Drug: Binimetinib
  • Experimental: Avelumab, binimetinib and talazoparib
    Open label
    Interventions:
    • Drug: Avelumab
    • Drug: Binimetinib
    • 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
127
Same as current
November 7, 2022
May 1, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
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]
United States
 
 
NCT03637491
B9991033
2018-000124-34 ( EudraCT Number )
No
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
Array BioPharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 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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