Metastatic Colorectal CancerPhase 2NCT02981524
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
A Phase 2 study testing CY, GVAX and Pembrolizumab in people with Metastatic Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CY, GVAX and Pembrolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 20 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
- Measurable disease by RECIST v1.1
- Age >18 years
- ECOG Performance Status of 0 to 1
- Estimated life expectancy of greater than 3 months.
- Adequate organ function as defined by study-specified laboratory tests
Show all 9Show fewer
- Must use acceptable form of birth control through the study and for 120 days after final dose of study drug
- Signed informed consent form
- Willing and able to comply with study procedures
Who cannot join
- Has a known additional malignancy that is progressing or requires active treatment.
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known malignant small bowel obstruction within the last 6 months.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- Systemically active steroid use.
- Has an active infection requiring systemic therapy.
Show all 22Show fewer
- Has a known history of active TB (Bacillus Tuberculosis).
- Infection with HIV or hepatitis B or C.
- Has history of (non-infectious) pneumonitis that required steroids.
- Must not require supplemental oxygen or have a pulse oximetry < 92% on room air.
- 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.
- Pregnant or lactating.
- Another investigational product within 28 days prior to receiving study drug.
- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
- Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug.
- Has received a live vaccine within 30 days of planned start of study therapy.
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- 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.
- Hypersensitivity to pembrolizumab or any of its excipients.
- 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.
- Presence of any tissue or organ allograft and history of allogeneic hematopoietic stem cell transplant.
- Unwilling or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
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
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CY, GVAX, Pembrolizumab
- Keywords
- Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases, Colonic Diseases
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYDrug
Also called Cyclophosphamide, Cytoxan
CY is administered intravenously at 200 mg/m2
GVAXBiological
Also called Colon cancer vaccine
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
PembrolizumabDrug
Also called KEYTRUDA, MK-3475
Pembrolizumab is administered intravenously at 200 mg
| Study group | Role | What they receive |
|---|---|---|
| CY/GVAX with Pembrolizumab | Experimental | 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. Receives: Drug: CY; Biological: GVAX; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: up to 1 year
Secondary outcomes (4)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0.
Measured: up to 1 year
Progression Free Survival (PFS)
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).
Measured: up to 1 year
Overall Survival (OS)
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.
Measured: Up to 1 year
Duration of Response (DOR)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start26 May 2017
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Nilofer Azad, MD, Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981524
- Sponsor's protocol ID
- J16154
- Other IDs
- IRB00114053, MISP53919
- Status last verified
- Feb 2020
- First submitted
- 1 Dec 2016
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yarchoan M, Huang CY, Zhu Q, Ferguson AK, Durham JN, Anders RA, Thompson ED, Rozich NS, Thomas DL 2nd, Nauroth JM, Rodriguez C, Osipov A, De Jesus-Acosta A, Le DT, Murphy AG, Laheru D, Donehower RC, Jaffee EM, Zheng L, Azad NS. A phase 2 study of GVAX colon vaccine with cyclophosphamide and pembrolizumab in patients with mismatch repair proficient advanced colorectal cancer. Cancer Med. 2020 Feb;9(4):1485-1494. doi: 10.1002/cam4.2763. Epub 2019 Dec 26.
PubMed 31876399
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02981524
- Acronym / sponsor ID
- J16154
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 26 May 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CY/GVAX with Pembrolizumab | Experimental | Drug: CY, Biological: GVAX, Drug: PembrolizumabDuring 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
- Measurable disease by RECIST v1.1
- Age >18 years
- ECOG Performance Status of 0 to 1
- Estimated life expectancy of greater than 3 months.
Key exclusion criteria (22 listed)
- Has a known additional malignancy that is progressing or requires active treatment.
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known malignant small bowel obstruction within the last 6 months.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- Systemically active steroid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYAlso: Cyclophosphamide, CytoxanCY is administered intravenously at 200 mg/m2 | Drug | CY/GVAX with Pembrolizumab |
| GVAXAlso: Colon cancer vaccineGVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting | Biological | CY/GVAX with Pembrolizumab |
| PembrolizumabAlso: KEYTRUDA, MK-3475Pembrolizumab is administered intravenously at 200 mg | Drug | CY/GVAX with Pembrolizumab |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 1 year
Progression Free Survival (PFS)
Time frame: up to 1 year
Overall Survival (OS)
Time frame: Up to 1 year
Duration of Response (DOR)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31876399Yarchoan M, Huang CY, Zhu Q, Ferguson AK, Durham JN, Anders RA, Thompson ED, Rozich NS, Thomas DL 2nd, Nauroth JM, Rodriguez C, Osipov A, De Jesus-Acosta A, Le DT, Murphy AG, Laheru D, Donehower RC, Jaffee EM, Zheng L, Azad NS. A phase 2 study of GVAX colon vaccine with cyclophosphamide and pembrolizumab in patients with mismatch repair proficient advanced colorectal cancer. Cancer Med. 2020 Feb;9(4):1485-1494. doi: 10.1002/cam4.2763. Epub 2019 Dec 26.
- Individual participant dataSharing planned: No
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilofer Azad, MD principal investigator
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CY, GVAX and Pembrolizumab in people with Metastatic Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02981524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.