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

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ClinicalTrials.gov Identifier: NCT02981524
Recruitment Status : Completed
First Posted : December 5, 2016
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: CY Biological: GVAX Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine


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 Name: Cyclophosphamide, Cytoxan

Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
Other Name: Colon cancer vaccine

Drug: Pembrolizumab
Pembrolizumab is administered intravenously at 200 mg
Other Name: KEYTRUDA, MK-3475




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02981524


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Nilofer Azad, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02981524     History of Changes
Other Study ID Numbers: J16154
IRB00114053 ( Other Identifier: JHMIRB )
MISP53919 ( Other Identifier: Merck and Company )
First Posted: December 5, 2016    Key Record Dates
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cyclophosphamide
Pembrolizumab
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological