Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03674827 |
|
Recruitment Status :
Terminated
(The study was terminated due to the review of the asset (VBIR-2) within the Sponsor's oncology portfolio; the study was not terminated because of safety concerns.)
First Posted : September 18, 2018
Last Update Posted : May 5, 2022
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 36 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 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 |
| Actual Primary Completion Date : | September 27, 2021 |
| Actual Study Completion Date : | September 27, 2021 |
| 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) |
- To evaluate Clinical Benefit Rate (CBR) [ Time Frame: Participant will have CT scans/MRI until disease progression for up to 3 years ]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.
- 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
- 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).
- 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)
- 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
- 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)
- 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
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
Show 34 study locations
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| 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: | May 5, 2022 |
| Last Verified: | April 2022 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
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 |