A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer
|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: NCT03380871|
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Lung Cancer Nonsquamous Nonsmall Cell Neoplasm of Lung||Biological: NEO-PV-01 Biological: Pembrolizumab Other: Adjuvant Drug: Carboplatin Drug: Pemetrexed||Phase 1|
This clinical trial will enroll patients with advanced or metastatic nonsquamous non-small cell lung carcinoma not having received treatment for metastatic disease. The five agents being used in this study are:
- A new, investigational, personalized cancer vaccine called "NEO-PV-01"
- Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
- A cancer drug called pembrolizumab (KEYTRUDA®)
- A chemotherapy called pemetrexed (ALIMPTA®)
- A chemotherapy called carboplatin
Both NEO-PV-01 and pembrolizumab are considered immunotherapies and work using the immune system to fight cancer. NEO-PV-01 is a custom made vaccine for you that is based on the specific targets on your cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective.
Pembrolizumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack your cancer. Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, including the type of cancer that you have. Recently, the FDA also approved the combination of Pembrolizumab with chemotherapy for the treatment of your type of lung cancer. This combination works better than each of the drugs on their own.
The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your immune response compared with pembrolizumab and chemotherapy treatment alone. The side effects of NEO-PV-01, pembrolizumab, and chemotherapy will be monitored and additional research tests will be done to assess your immune response to your cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 1B Study of NEO-PV-01 With Pembrolizumab Plus Chemotherapy in Patients With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer|
|Actual Study Start Date :||May 4, 2018|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||February 5, 2021|
Experimental: NEO-PV-01/Adjuvant + pembrolizumab + chemotherapy
Pembrolizumab at a dose of 200 mg administered by intravenous infusion (IV) plus chemotherapy with carboplatin (AUC 5) + pemetrexed (500 mg/m2) every 3 weeks for 4 cycles. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with pembrolizumab.
Personal Cancer Vaccine
monoclonal antibody against PDL1
Other Name: KEYTRUDA
Other Name: ALIMTA
- The rate of adverse events and severe adverse events leading to treatment discontinuation [ Time Frame: Baseline through 90 days after the last dose of pembrolizumab ]Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
- Objective Response Rate (ORR) [ Time Frame: Baseline through 104 weeks ]Objective Response Rate (ORR), defined as the proportion of patients who achieve complete response (CR) or partial response (PR) based on Response Criteria in Solid Tumors (RECIST) v1.1
- Clinical Benefit Rate [ Time Frame: Baseline through 104 weeks ]Clinical Benefit Rate (CBR), defined as the proportion of patients who achieve a CR, PR, or stable disease (SD) based on RECIST v1.1
- Duration of Response [ Time Frame: Baseline through 104 weeks ]Duration of Response, DOR, defined as the date of the first documentation of a confirmed response to the date of the first documented PD based on RECIST v1.1
- Response Conversion Rate [ Time Frame: Baseline to 104 weeks ]Response Conversion Rate (RCR), defined as the proportion of patients who improve in RECIST v1.1 category subsequent to vaccination (eg. PD to SD/PR/CR, SD to PR/CR, PR/CR).
- Progression Free Survival [ Time Frame: Baseline through 104 weeks ]Progression Free Survival (PFS), defined as the time from the date of first dosing to the date of first documented PD or death
- Overall Survival [ Time Frame: Baseline of pembrolizumab through 104 weeks ]Overall Survival (OS), defined from the date of enrollment and death from any cause
- T Cell Immune Responses [ Time Frame: Day 1 of pembrolizumab/chemotherapy through 104 weeks ]Antigen-specificity in peripheral CD8+ and CD4+ T cell responses following treatment with NEO-PV-01, pembrolizumab, and chemotherapy.
- Analysis of Tumor Biopsies [ Time Frame: Day 1 of pembrolizumab/chemotherapy through 104 weeks ]Analysis of tumor biopsies following treatment of NEO-PV-01, pembrolizumab, and chemotherapy
- Overall Response Rate [ Time Frame: Baseline through 104 weeks ]To determine the anti-tumor activity, as assessed by ORR by iRECIST
- Progression Free Survival [ Time Frame: Baseline through 104 weeks ]To determine the anti-tumor activity, as assessed by PFS by iRECIST
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): NCT03380871
|United States, California|
|University of California - Los Angeles|
|Santa Monica, California, United States, 90404|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63130|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Mark DeMario, MD||BioNTech US Inc.|