Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer

February 8, 2021 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer

This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
  2. Measurable disease by RECIST v1.1
  3. Age >18 years
  4. ECOG Performance Status of 0 to 1
  5. Estimated life expectancy of greater than 3 months.
  6. Adequate organ function as defined by study-specified laboratory tests
  7. Must use acceptable form of birth control through the study and for 120 days after final dose of study drug
  8. Signed informed consent form
  9. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Has a known additional malignancy that is progressing or requires active treatment.
  2. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  3. Has known malignant small bowel obstruction within the last 6 months.
  4. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
  5. Systemically active steroid use.
  6. Has an active infection requiring systemic therapy.
  7. Has a known history of active TB (Bacillus Tuberculosis).
  8. Infection with HIV or hepatitis B or C.
  9. Has history of (non-infectious) pneumonitis that required steroids.
  10. Must not require supplemental oxygen or have a pulse oximetry < 92% on room air.
  11. Conditions, including therapy, laboratory abnormalities, psychiatric or substance abuse disorders, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
  12. Pregnant or lactating.
  13. Another investigational product within 28 days prior to receiving study drug.
  14. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
  15. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug.
  16. Has received a live vaccine within 30 days of planned start of study therapy.
  17. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
  18. Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
  19. Hypersensitivity to pembrolizumab or any of its excipients.
  20. Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX vaccine.
  21. Presence of any tissue or organ allograft and history of allogeneic hematopoietic stem cell transplant.
  22. Unwilling or unable to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CY/GVAX with Pembrolizumab
During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle.
Drug: CY
CY is administered intravenously at 200 mg/m2
Other Names:
  • Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
Other Names:
  • Colon cancer vaccine
Drug: Pembrolizumab
Pembrolizumab is administered intravenously at 200 mg
Other Names:
  • KEYTRUDA, MK-3475

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 1 year
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 1 year
Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0.
up to 1 year
Progression Free Survival (PFS)
Time Frame: up to 1 year
Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1).
up to 1 year
Overall Survival (OS)
Time Frame: Up to 1 year
OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier.
Up to 1 year
Duration of Response (DOR)
Time Frame: 1 year
Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Nilofer Azad, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

March 20, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J16154
  • IRB00114053 (Other Identifier: JHMIRB)
  • MISP53919 (Other Identifier: Merck and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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