A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

NCT02880371

Last updated date
Study Location
UCLA Department of Medicine
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
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

All Study Parts:

- Diagnosis of cancer that has been histologically or cytologically confirmed

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

Part A (1 of the following):

- Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer, bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST v1.1 and meets 1 of the following criteria:

- is refractory to standard of care

- no standard therapy available

- patient refuses standard therapy

- Advanced, unresectable, or metastatic melanoma with or without prior treatment and measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1

- Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score [TPS] ≥ 50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1 of the following):

- 1) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic aberrations

- 2) Disease progression on or after platinum-containing chemotherapy;

- 3) If tumor has EGFR or ALK genomic aberrations, disease progression on an FDA-approved therapy for EGFR or ALK genomic tumor aberrations

Phase 2 (1 of the following):

- Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy

- Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with measurable disease as defined by RECIST 1.1, that had progressed within 6 months of completing ≥ 4 cycles of platinum-based therapy

- Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with measurable disease as defined by RECIST v1.1 in patients who have received at least one prior line of systemic therapy for their disease

Key

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


1. Prior treatment as follows:


- Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4
[CTLA-4] inhibitor).


NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was
administered as adjuvant therapy and treatment was completed at least 3 months prior
to enrollment.


- Phase 2:


- A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor.


- prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4
inhibitor)


2. Symptomatic brain metastasis at screening


3. Active autoimmune disease, documented history of autoimmune syndrome or disease, or a
chronic medical condition that requires chronic steroid therapy or immunosuppressive
medication


4. History of pneumonitis or interstitial lung disease


5. Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or study drug
administration or that may interfere with the interpretation of study results and, in
the judgment of the Investigator, would make the patient an inappropriate candidate
for the study


6. Ocular melanoma

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors
Official Title  ICMJE A Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors
Brief Summary This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).
Detailed Description

ARRY-382 is an inhibitor of CSF1R (colony-stimulating factor-1 receptor).

Each phase of the study consists of a 28-day screening period; 21-day treatment cycles with the combination of ARRY-382 and pembrolizumab until disease progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, or death (or other discontinuation criteria are met), and a 30-day safety follow-up period. Patients in all cohorts/phases will be monitored for overall survival (OS) until 1 year after the date of the last patient's first visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: ARRY-382
    ARRAY-382 will be taken by mouth once daily at a fixed dose.
  • Drug: Pembrolizumab
    Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Study Arms  ICMJE
  • Experimental: Phase 1b/Part A
    Patients in Part A will receive escalating doses of single-agent ARRY-382 in combination with 2 mg/kg pembrolizumab.
    Interventions:
    • Drug: ARRY-382
    • Drug: Pembrolizumab
  • Experimental: Phase 2
    Patients in Phase 2 will receive the MTD/RP2D dose of ARRY-382 determined during Part A in combination with 200mg pembrolizumab.
    Interventions:
    • Drug: ARRY-382
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2020)
82
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2016)
70
Actual Study Completion Date  ICMJE October 24, 2019
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

All Study Parts:

  • Diagnosis of cancer that has been histologically or cytologically confirmed
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Part A (1 of the following):

  • Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer, bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST v1.1 and meets 1 of the following criteria:

    • is refractory to standard of care
    • no standard therapy available
    • patient refuses standard therapy
  • Advanced, unresectable, or metastatic melanoma with or without prior treatment and measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1
  • Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score [TPS] ? 50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1 of the following):

    • 1) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic aberrations
    • 2) Disease progression on or after platinum-containing chemotherapy;
    • 3) If tumor has EGFR or ALK genomic aberrations, disease progression on an FDA-approved therapy for EGFR or ALK genomic tumor aberrations

Phase 2 (1 of the following):

  • Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy
  • Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with measurable disease as defined by RECIST 1.1, that had progressed within 6 months of completing ? 4 cycles of platinum-based therapy
  • Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with measurable disease as defined by RECIST v1.1 in patients who have received at least one prior line of systemic therapy for their disease

Key Exclusion Criteria

  1. Prior treatment as follows:

    • Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4 [CTLA-4] inhibitor).

    NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was administered as adjuvant therapy and treatment was completed at least 3 months prior to enrollment.

    • Phase 2:

      • A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor.
      • prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4 inhibitor)
  2. Symptomatic brain metastasis at screening
  3. Active autoimmune disease, documented history of autoimmune syndrome or disease, or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication
  4. History of pneumonitis or interstitial lung disease
  5. Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study
  6. Ocular melanoma
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02880371
Other Study ID Numbers  ICMJE ARRAY-382-201
C4261001 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP