Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: CY; GVAX; Pembrolizumab
Intervention description: CY is administered intravenously at 200 mg/m2; GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting; Pembrolizumab is administered intravenously at 200 mg
Intervention MeSH terms: Cyclophosphamide; Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

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.
    

Eligibility 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.