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A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

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ClinicalTrials.gov Identifier: NCT03674827
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung cancer and metastatic triple-negative breast cancer.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Triple-negative Breast Cancer Biological: PF-06936308 Phase 1

Detailed Description:
By enrolling patients with advanced NSCLC and metastatic TNBC according to the enrollment criteria, this study will evaluate the first-in-patient safety, PK, PD and early signs of efficacy of the vaccine-based immunotherapy regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES AND TREATMENT INTENSIFICATION OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN-2 (VBIR-2) (PF-06936308) FOR ADVANCED NON-SMALL CELL LUNG CANCER AND METASTATIC TRIPLE-NEGATIVE BREAST CANCER
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : December 25, 2023
Estimated Study Completion Date : December 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06936308
Dose escalation
Biological: PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Other Name: Vaccine-based immunotherapy regimen-2 (VBIR-2)




Primary Outcome Measures :
  1. Incidence and grade of treatment-emergent adverse events including DLTs [ Time Frame: Baseline up to Day 29 in Cycle 1 (each cycle is 4 months) ]
    DLTs in order to determine the maximum tolerated dose


Secondary Outcome Measures :
  1. To evaluate the immune response elicited by VBIR 2 to selected tumor antigens. [ Time Frame: Baseline up to Cycle 1 Day 85 (each cycle is 4 months), at Day 1 and Day 99 of Cycle 2; every 5 months therafter up to Month 22; every 6 months thereafter up to 3 years ]
    Cellular immune response specific to selected tumor antigens.

  2. To evaluate the antibody response to selected tumor-antigens [ Time Frame: Baseline up to Day 85 Cycle 1 (each cycle is 4 months); at Day 1 and Day 99 Cycle 2; every 5 months thereafter up to Mont 22; every 6 months thereafter up to 3 years ]
    Antibody response to selected tumor-antigens

  3. Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter (Cmax) [ Time Frame: Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years ]
    Maximum observed plasma concentration of tremelimumab and PF-06801591 (Cmax).

  4. Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter (Tmax) [ Time Frame: Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years ]
    Time to maximum concentration of tremelimumab and PF-06801591 (Tmax)

  5. Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter AUC [ Time Frame: Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years ]
    Area under the curve from time zero extrapolated to infinity of tremelimumab and PF-06801591

  6. Tremelimumab and anti PD-1 (PF-06801591) after multiple doses PK parameter (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years ]
    Trough concentration after multiple doses of tremelimumab and PF-06801591 (Ctrough)

  7. the anti drug antibody (ADA) response of tremelimumab and anti PD 1 (PF 06801591) after SC administration with the other components. [ Time Frame: Day 1, Day 29 and Day 85 on Cycle 1 (each cycle is 4 months); Day 29 on Cycle 2, every 4 months thereafter up to Month 22; every 6 months thereafter up to 3 years ]
    Incidence and titers of anti-drug antibodies against tremelimumab and PF-06801591



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: -Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer

-Adequate bone marrow, kidney, and liver function

Exclusion Criteria:

  • ECOG performance status greater than or equal to 2
  • concurrent immunotherapy
  • History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
  • History of inflammatory bowel disease.
  • Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
  • Presence of any surgical or traumatic metal implants at the site of administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674827


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
UCSD Medical Center - Encinitas Not yet recruiting
Encinitas, California, United States, 92024
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital) Not yet recruiting
La Jolla, California, United States, 92037
UC San Diego Perlman Medical Offices Not yet recruiting
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
UC San Diego Medical Center - Hillcrest Not yet recruiting
San Diego, California, United States, 92103
UCSD Medical Center - Vista Not yet recruiting
Vista, California, United States, 92081
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute, Inc. Not yet recruiting
Tampa, Florida, United States, 33612
United States, Illinois
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy Not yet recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center Not yet recruiting
Chicago, Illinois, United States, 60637
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital Not yet recruiting
New Lenox, Illinois, United States, 60451
Orland Park - University of Chicago Center for Advanced Care Not yet recruiting
Orland Park, Illinois, United States, 60462
United States, Indiana
Horizon Oncology Research, LLC Recruiting
Lafayette, Indiana, United States, 47905
United States, Kansas
The University of Kansas Cancer Center, Investigational Drug Services Recruiting
Fairway, Kansas, United States, 66205
The University of Kansas Clinical Research Center Recruiting
Fairway, Kansas, United States, 66205
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute Pharmacy Not yet recruiting
Louisville, Kentucky, United States, 40202
Norton Cancer Institute, Norton Healthcare Pavilion Not yet recruiting
Louisville, Kentucky, United States, 40202
Norton Hospital Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
Siteman Cancer Center - West County Recruiting
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Washington University Infusion Center Pharmacy Recruiting
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center - South County Recruiting
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center - St. Peters Recruiting
Saint Peters, Missouri, United States, 63376
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Utah
University of Utah, Huntsman Cancer Hospital Recruiting
Salt Lake City, Utah, United States, 84112
University of Utah, Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington Medical Center - Translational Research Unit (TRU) Not yet recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03674827     History of Changes
Other Study ID Numbers: C3621001
VBIR-2 ( Other Identifier: Alias Study Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs