Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03674827
• Other study ID #: C3621001
• Secondary ID: VBIR-2
• Status: Terminated
• Phase: Phase 1
• Start date: November 27, 2018
• Est. completion date: September 27, 2021

Study information

• Verified date: April 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Biological:
• PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Siteman Cancer Center - West County	Creve Coeur	Missouri
United States	UCSD Medical Center - Encinitas	Encinitas	California
United States	The University of Kansas Cancer Center, Investigational Drug Services	Fairway	Kansas
United States	The University of Kansas Clinical Research Center	Fairway	Kansas
United States	UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)	La Jolla	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	UC San Diego Perlman Medical Offices	La Jolla	California
United States	Horizon Oncology Research, LLC	Lafayette	Indiana
United States	InnerVision Advanced Medical Imaging	Lafayette	Indiana
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	Norton Cancer Institute Downtown	Louisville	Kentucky
United States	Norton Cancer Institute Pharmacy, Downtown Pharmacy	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	University of Chicago Comprehensive Cancer Center at Silver Cross Hospital	New Lenox	Illinois
United States	Orland Park - University of Chicago Center for Advanced Care	Orland Park	Illinois
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Siteman Cancer Center - South County	Saint Louis	Missouri
United States	Washington University Infusion Center Pharmacy	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Siteman Cancer Center - St. Peters	Saint Peters	Missouri
United States	University of Utah, Huntsman Cancer Hospital	Salt Lake City	Utah
United States	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah
United States	UC San Diego Medical Center - Hillcrest	San Diego	California
United States	UCLA Hematology/Oncology - Parkside	Santa Monica	California
United States	UCLA Hematology/Oncology - Santa Monica	Santa Monica	California
United States	University of Washington Medical Center - Translational Research Unit (TRU)	Seattle	Washington
United States	H Lee Moffitt Cancer Center & Research Institute Inc	Tampa	Florida
United States	UCSD Medical Center - Vista	Vista	California
United States	The University of Kansas Cancer Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate Clinical Benefit Rate (CBR)	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.	Participant will have CT scans/MRI until disease progression for up to 3 years
Primary	Incidence and grade of treatment-emergent adverse events including DLTs	DLTs in order to determine the maximum tolerated dose	Baseline up to Day 29 in Cycle 1 (each cycle is 4 months)
Secondary	Tremelimumab and sasanlimab single dose PK parameter (Cmax)	Maximum observed plasma concentration of tremelimumab and sasanlimab (Cmax).	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
Secondary	Tremelimumab and sasanlimab single dose PK parameter (Tmax)	Time to maximum concentration of tremelimumab and sasanlimab (Tmax)	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
Secondary	Tremelimumab and sasanlimab single dose PK parameter AUC	Area under the curve from time zero extrapolated to infinity of tremelimumab and sasanlimab	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
Secondary	Tremelimumab and sasanlimab after multiple doses PK parameter (Ctrough)	Trough concentration after multiple doses of tremelimumab and sasanlimab (Ctrough)	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
Secondary	Anti drug antibody (ADA) response of tremelimumab and sasanlimab after SC administration with the other components.	Incidence and titers of anti-drug antibodies against tremelimumab and sasanlimab	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
Secondary	Objective response rate using RECIST 1.1	Proportion of participants who achieve complete response or partial response.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Secondary	Duration of response using RECIST 1.1	Median time from first response (complete or partial) until disease progression for up to 3 years in responders.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Secondary	Progression-free survival using RECIST 1.1	Kaplan-Meier curve for progression up to 3 years.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years

External Links

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