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

Primary Purpose

Pancreatic Cancer

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Avelumab

Binimetinib

Talazoparib

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring KRAS, NRAS, PDAC, Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Metastatic pancreatic ductal adenocarcinoma; or
2. 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.

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.

Sites / Locations

Highlands Oncology Group
Highlands Oncology Group
Highlands Oncology Group
California Cancer Associates for Research and Excellence, Inc (cCARE)
University of Colorado Denver CTO (CTRC)
University of Colorado Hospital
Horizon Oncology Research, LLC
UPMC Hillman Cancer Center
The University of Texas MD Anderson Cancer Center
University of Utah, Huntsman Cancer Hospital
University of Utah, Huntsman Cancer Institute
Institut Jules Bordet
UZ Gent
Singapore National Eye Centre
Singapore General Hospital
SingHealth Investigational Medicine Unit
National Heart Centre Singapore
National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Avelumab and binimetinib

Avelumab, binimetinib and talazoparib

Binimetinib and talazoparib.

Arm Description

Open label

Open label.

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLTs) During the Primary DLT Evaluation Period (Cycle 1) in Phase 1b

Any adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to study drugs and met DLT criteria. DLT was defined as hematologic: Grade 4 neutropenia lasting>5 days; febrile neutropenia; neutropenic infection; Grade >=3 thrombocytopenia with bleed; Grade 4 thrombocytopenia; Grade 4 anemia; non-hematologic: Grade ≥3 toxicities (with some exceptions) ; Grade≥3 creatinine phosphokinase (CPK) with creatinine >= 1.5xbaseline; Grade 3 troponin increase with cardiac toxicity; potential Hy's Law cases; eye disorders: retinopathy or retinal detachment Grade≥3; retinal vascular disorder; Grade≥3 uveitis, blurred vision, flashing lights, floaters or others for >21 consecutive days; other Grade 4; cardiac disorders: absolute LVEF decrease >10% and the LVEF was below LLN; other Grade≥3; respiratory disorders: interstitial lung disease Grade≥2; bronchospasm Grade 3; skin and subcutaneous tissue disorders; non-adherence to treatment schedule; dose reductions.

Phase 2: Confirmed Objective Response (OR) Based on Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Confirmed OR, defined as a complete response (CR) or partial response (PR) per RECIST v1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Both CR and PR must be confirmed by repeated assessments performed no less than 4 weeks after the criteria for response were first met.

Secondary Outcome Measures

Number of Participants With Adverse Events During the On-Treatment Period

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Number of Participants With Hematology Laboratory Abnormalities During the On-Treatment Period Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Laboratory abnormalities were graded by NCI CTCAE version 4.03. Anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased were evaluated. This outcome measure calculated the number of participants with laboratory abnormalities whose maximum on-treatment CTCAE Grade were 1-4.

Number of Participants With Chemistry Laboratory Abnormalities During the On-Treatment Period Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Laboratory abnormalities were graded by NCI CTCAE version 4.03. Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase (cpk) increased, creatinine increased, gamma-glutamyl transferase (ggt) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased, serum amylase increased were evaluated. This outcome measure calculated the number of participants with laboratory abnormalities whose maximum on-treatment CTCAE Grade were 1-4.

Predose Concentration During Multiple Dosing (Ctrough) for Avelumab

Ctrough was the pre-dose concentration during multiple dosing and was directly observed from data. The lower limit of quantification (LLQ) was 0.20 microgram per milliliter. Concentration values below the LLQ were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.

Predose Concentration During Multiple Dosing (Ctrough) for Binimetinib

Ctrough was directly observed from data. Ctrough = concentration prior to study drug administration. The LLQ was 1.00 ng/mL. Concentration values below the LLQ were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.

Predose Concentration During Multiple Dosing (Ctrough) for Talazoparib

Ctrough was directly observed from data. Ctrough = concentration prior to study drug administration. The LLQ was 25 pg/mL. Concentration values below the LLQ were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.

Maximum Observed Plasma Concentration (Cmax) for Avelumab

Cmax was the maximum observed plasma concentration and was directly observed from data. The LLQ was 0.20 microgram per milliliter. Concentration values below the LLQ were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.

Maximum Observed Plasma Concentration (Cmax) for Binimetinib

Cmax was the maximum observed plasma concentration and was directly observed from data. The LLQ was 1.00 ng/mL. Concentration values below the LLQ were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.

Number of Participants With Anti-drug Antibody (ADA) Categories

Samples positive for ADA were analyzed for titer. Blood samples were collected for avelumab immunogenicity testing. Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab. Treatment-induced ADA was defined as participants with ADA-negative at baseline and had at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive post-baseline ADA result.

Neutralizing Antibodies (nAb) Against Avelumab

The category of nAb included nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response.

Percentage of Participants With Confirmed Objective Response (OR) in Phase 1b Based on Investigator Assessment (RECIST v1.1)

OR is defined as complete response (CR) or partial response (PR) according to RECIST v1.1 from the 'start date' (date of first study treatment) until the date of the first documentation of progressive disease (PD). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Clopper-Pearson method was used.

Progression-Free Survival (PFS) Based on Investigator Assessment (RECIST v1.1) in Phase 1b

PFS is defined as the time from the 'start date' (date of first study treatment) to the date of the first documentation of PD or death due to any cause, whichever occurs first. PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. CIs were calculated using Brookmeyer and Crowley method.

Overall Survival (OS) in Phase 1b

OS is defined as the time from the 'start date' (date of first study treatment) to the date of death due to any cause. CIs were calculated using Brookmeyer and Crowley method.

Time-to-Tumor Response (TTR) in Phase 1b

TTR is defined, for patients with an OR, as the time from the 'start date' (date of first study treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. OR is defined as complete response (CR) or partial response (PR) according to RECIST v1.1 from the 'start date' until the date of the first documentation of progressive disease (PD). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy.

Duration of Response (DR) in Phase 1b

DR is defined, for patients with OR, as the time from the first documentation of objective response (CR or PR) to the date of first documentation of PD or death due to any cause. OR is defined as complete response (CR) or partial response (PR) according to RECIST v1.1 from the 'start date' until the date of the first documentation of progressive disease (PD). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy.

Phase 2: Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression, DNA Damage Repair (DDR) Gene Alterations, and Tumor Mutational Burden (TMB) in Baseline Tumor Tissue.

PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. DDR gene alterations was defined as the number of somatic and germline mutations present in a panel of genes associated with DDR in baseline tumor derived nucleic acid, in germline nucleic acid and in circulating tumor DNA. TMB was defined as determination/estimation of the frequency of mutations (total and non-synonymous) present in baseline tumor derived nucleic acid samples and in baseline circulating tumor DNA.

Full Information

NCT ID

NCT03637491

First Posted

August 10, 2018

Last Updated

December 28, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03637491

Brief Title

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

Official Title

A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Available clinical data has shown limited anti-tumor activity and reaching target study drug dose levels may not be feasible.

Study Start Date

August 15, 2018 (Actual)

Primary Completion Date

December 3, 2020 (Actual)

Study Completion Date

February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

This is a Phase 1b/2, open label, multi-center, safety, clinical activity, pharmacokinetic (PK), and pharmacodynamics (PD) study of combinations of avelumab, binimetinib and talazoparib in adult patients with metastatic pancreatic ductal adenocarcinoma and other locally advanced or metastatic KRAS- or NRAS-mutant solid tumors. The Phase 1b part of this study will initially assess doublet drug combinations 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

KRAS, NRAS, PDAC, Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Avelumab and binimetinib

Arm Type

Experimental

Arm Description

Open label

Arm Title

Avelumab, binimetinib and talazoparib

Arm Type

Experimental

Arm Description

Open label

Arm Title

Binimetinib and talazoparib.

Arm Type

Experimental

Arm Description

Open label.

Intervention Type

Drug

Intervention Name(s)

Avelumab

Other Intervention Name(s)

MSB0010718C

Intervention Description

IV treatment

Intervention Type

Drug

Intervention Name(s)

Binimetinib

Other Intervention Name(s)

MEK162, ARRY-438162

Intervention Description

Oral treatment

Intervention Type

Drug

Intervention Name(s)

Talazoparib

Other Intervention Name(s)

MDV3800, BMN 673

Intervention Description

Oral treatment

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLTs) During the Primary DLT Evaluation Period (Cycle 1) in Phase 1b

Description

Time Frame

From date of first study treatment to day 28 of study treatment (Up to 28 days)

Title

Phase 2: Confirmed Objective Response (OR) Based on Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Description

Time Frame

From date of first study treatment until the date of first documentation of progressive disease or death due to any cause (assessed for a maximum duration of up to 31 months).

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events During the On-Treatment Period

Description

Time Frame

From the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day) assessed for a maximum duration of up to 31 months

Title

Description

Time Frame

Prior to study drug administration on Days 1 and 15 of each treatment cycle, until 30 days after last dose (assessed for a maximum duration of up to 31 months)

Title

Number of Participants With Chemistry Laboratory Abnormalities During the On-Treatment Period Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Description

Time Frame

Prior to study drug administration on Days 1 and 15 of each treatment cycle, until 30 days after last dose (assessed for a maximum duration of up to 31 months)

Title

Predose Concentration During Multiple Dosing (Ctrough) for Avelumab

Description

Time Frame

Pre-dose on Day 1, and Day 15 of Cycle 1 (each cycle is 28 days); Day 1 and Day 15 of Cycle 2; and Day 1 of Cycles 3, 5, 9 and 12.

Title

Predose Concentration During Multiple Dosing (Ctrough) for Binimetinib

Description

Time Frame

Predose on Day 15 of Cycle 1 (each cycle is 28 days), Day 1 and Day 15 of Cycle 2, Day 1 of Cycle 3 for avelumab+binimetinib groups, and on Day 8 and Day 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3 for binimetinib+talazoparib groups

Title

Predose Concentration During Multiple Dosing (Ctrough) for Talazoparib

Description

Time Frame

Pre-dose on Days 1, 8 and Day 15 of Cycle 1 (each cycle is 28 days), and on Day 1 of Cycle 2 and Cycle 3

Title

Maximum Observed Plasma Concentration (Cmax) for Avelumab

Description

Time Frame

Post dose on Day 1, and Day 15 of Cycle 1 (each cycle is 28 days); Day 1 and Day 15 of Cycle 2; and Day 1 of Cycles 3, 5, 9 and 12

Title

Maximum Observed Plasma Concentration (Cmax) for Binimetinib

Description

Time Frame

Post dose on Day 1 and Day 8 of Cycle 1

Title

Number of Participants With Anti-drug Antibody (ADA) Categories

Description

Time Frame

from the first dose of study up to Day 1 of Cycle 12 for a maximum of 12 months

Title

Neutralizing Antibodies (nAb) Against Avelumab

Description

The category of nAb included nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response.

Time Frame

from the first dose of study up to Day 1 of Cycle 12 for a maximum of 12 months

Title

Percentage of Participants With Confirmed Objective Response (OR) in Phase 1b Based on Investigator Assessment (RECIST v1.1)

Description

Time Frame

From date of first study treatment until the date of first documentation of progressive disease or death due to any cause (assessed for a maximum duration of up to 31 months).

Title

Progression-Free Survival (PFS) Based on Investigator Assessment (RECIST v1.1) in Phase 1b

Description

Time Frame

From date of first study treatment until the date of first documentation of progressive disease or death due to any cause (assessed for a maximum duration of up to 31 months).

Title

Overall Survival (OS) in Phase 1b

Description

OS is defined as the time from the 'start date' (date of first study treatment) to the date of death due to any cause. CIs were calculated using Brookmeyer and Crowley method.

Time Frame

From date of first study treatment until the date of death due to any cause (assessed for a maximum duration of up to 31 months).

Title

Time-to-Tumor Response (TTR) in Phase 1b

Description

Time Frame

From date of first study treatment until the date of first documentation of progressive disease or death due to any cause (assessed for a maximum duration of up to 31 months).

Title

Duration of Response (DR) in Phase 1b

Description

Time Frame

From date of first study treatment until the date of first documentation of progressive disease or death due to any cause (assessed for a maximum duration of up to 31 months).

Title

Phase 2: Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression, DNA Damage Repair (DDR) Gene Alterations, and Tumor Mutational Burden (TMB) in Baseline Tumor Tissue.

Description

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Highlands Oncology Group

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Highlands Oncology Group

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

California Cancer Associates for Research and Excellence, Inc (cCARE)

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

University of Colorado Denver CTO (CTRC)

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Horizon Oncology Research, LLC

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

UPMC Hillman Cancer Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Utah, Huntsman Cancer Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

University of Utah, Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Singapore National Eye Centre

City

Singapore

ZIP/Postal Code

168751

Country

Singapore

Facility Name

Singapore General Hospital

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

SingHealth Investigational Medicine Unit

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

National Heart Centre Singapore

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

National Cancer Centre Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Citations:

PubMed Identifier

32379297

Citation

Sun C, Fang Y, Labrie M, Li X, Mills GB. Systems approach to rational combination therapy: PARP inhibitors. Biochem Soc Trans. 2020 Jun 30;48(3):1101-1108. doi: 10.1042/BST20191092.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B9991033

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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