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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 : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer.

Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.


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

Detailed Description:

The study is divided into two parts, Dose Escalation (Part 1) in participants with NSCLC and TNBC without acceptable alternative treatment options, followed by Dose Expansion (Part 2) in participants with NSCLC who have progressed on or after treatment with platinum-based chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or sequentially with chemotherapy.

Part 1 has been completed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses 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: Dose escalation (Part 1)
Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.
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)

Experimental: Dose Expansion (Part 2)
Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.
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. To evaluate Clinical Benefit Rate (CBR) [ Time Frame: Participant will have CT scans/MRI every 8 weeks until disease progression for up to 3 years to measure change from baseline ]
    Proportion of participants who achieve complete response, partial response or stable disease for more than 6 months at 12, 24 and 36 months using RECIST 1.1. criteria.

  2. 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. Tremelimumab and sasanlimab 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 sasanlimab (Cmax).

  2. Tremelimumab and sasanlimab 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 sasanlimab (Tmax)

  3. Tremelimumab and sasanlimab 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 sasanlimab

  4. Tremelimumab and sasanlimab 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 sasanlimab (Ctrough)

  5. Anti drug antibody (ADA) response of tremelimumab and sasanlimab 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 sasanlimab

  6. Objective response rate using RECIST 1.1 [ Time Frame: Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years ]
    Proportion of participants who achieve complete response or partial response.

  7. Duration of response using RECIST 1.1 [ Time Frame: Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years ]
    Median time from first response (complete or partial) until disease progression for up to 3 years in responders.

  8. Progression-free survival using RECIST 1.1 [ Time Frame: Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years ]
    Kaplan-Meier curve for progression up to 3 years.



Information from the National Library of Medicine

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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:

Part 1:Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer. Adequate bone marrow, renal and liver function.

Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a CPI and platinum-based chemotherapy. Adequate bone marrow, renal and liver function.

Exclusion Criteria:

  • Known symptomatic brain metastases
  • 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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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    
Other Study ID Numbers: C3621001
VBIR-2 ( Other Identifier: Alias Study Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
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