Colorectal CancerPhase 2NCT02375672
Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer
A Phase 2 study testing Pembrolizumab and mFOLFOX6 in people with Colorectal Cancer, run by Hoosier Cancer Research Network at 3 sites in United States.
Trial summary
This is a multi-institutional, single arm, open-label, phase II study, including a safety run-in cohort. No randomization or blinding involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Pembrolizumab and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 May 2015to 8 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the trial and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Be ≥ 18 years of age on day of signing informed consent.
- Have a performance status of 0 or 1 on the ECOG Performance Scale within 14 days prior to registration.
- Have histological or cytological evidence of colorectal adenocarcinoma with confirmation of metastatic disease either by pathologic or radiologic findings.
- Have identified tissue from an archival tissue sample (preferably from a metastasis, but sample from primary tumor allowable) or newly obtained core or excisional biopsy of a tumor lesion.
- Have had no prior systemic therapy for advanced or metastatic disease. Prior adjuvant therapy should have been completed at least 9 months from documentation of metastatic disease. Prior palliative radiotherapy allowed if toxicities resolved to grade 1 or baseline.
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- Have measurable disease according to RECIST v1.1 obtained by imaging within 28 days prior to registration.
- Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to study registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Subjects of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are those who meet the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; OR has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Who cannot join
- Has clearly resectable colon cancer liver metastases (CCLM), for example oligometastatic disease involving only one lobe of the liver. Subjects with suspected resectable CCLM should undergo evaluation by a liver surgeon prior to enrollment to document the incurable nature of their disease.
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of registration. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol.
- Is unable to receive a port or peripherally inserted central catheter (PICC).
- Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
- Has previously undergone organ or bone marrow transplantation and is on immunosuppressive therapy
- Has had major surgery or significant traumatic injury within 4 weeks of study registration. Subjects must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. A diagnostic or research biopsy does not exclude subjects from enrollment. Placement of a vascular access device such as a Port-A-Cath is not considered major surgery
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- Has baseline peripheral neuropathy/paresthesia grade ≥ 1.
- Has a known additional malignancy within the past 3 years. Exceptions include treated localized basal cell or squamous cell carcinoma of the skin, in situ cervical or vulvar carcinoma that has undergone potentially curative therapy, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer (Gleason sore 6). Any cancer curatively treated > 3 years prior to registration with no clinical evidence of recurrence is permitted
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to trial registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial registration.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions to the rule: subjects with vitiligo; subjects with resolved childhood asthma/atopy; subjects that require intermittent use of bronchodilators or local steroid injections; subjects with hypothyroidism stable on hormone replacement or patients with Sjögren's syndrome
- Has a history of pneumonitis that required steroids or current pneumonitis.
- Has known history of active tuberculosis.
- Has an active infection requiring systemic therapy (≥ grade 2) for more than 3 days within 1 week of enrollment.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of pembrolizumab (MK-3475).
- Has known hypersensitivity to fluorouracil (5FU), oxaliplatin, or other platinum agents.
- Known hypersensitivity to pembrolizumab or any of its excipients.
- Has known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not required)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has known active Hepatitis B unless subject has been on antiviral agents for at least 2 months (baseline testing not required)
- Has a known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing is not required).
- Has received a live vaccine within 30 days prior to trial registration.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has any other psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the subject before registration in the trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University: Winship Cancer Institute
Atlanta, Georgia, 30322
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Multi-Center, Single Arm, Phase II Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer: HCRN GI14-186
This is a multi-institutional, single arm, open-label, phase II study, including a safety run-in cohort. No randomization or blinding involved.
Read the detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
- Oxaliplatin 85 mg/m2 IV with
- Leucovorin 400 mg/m2 IV followed by
- 5FU 400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion
Pembrolizumab (MK-3475) IV over 30 minutes every 3 weeks
SAFETY RUN-IN COHORT:
The safety run-in cohort will include 6 subjects treated with 200 mg (fixed) IV infusion of pembrolizumab (MK-3475) every 3 weeks plus standard-dose mFOLFOX6 given every 2 weeks. These first 6 subjects will be followed for 4 weeks for dose limiting toxicities (DLT) before enrolling an additional 24 patients. If a DLT is observed in no more than 1 of 6 subjects, the trial will continue with enrolling subjects to the remainder of the phase II portion of the study. Otherwise, 6 additional subjects will be enrolled at dose level -1. If no more than one DLT is observed, then phase II will enroll subjects at dose level -1 for the total expected number of accrual.
Disease evaluation every 8 weeks or after every 2 cycles
Demonstrate adequate organ function as defined by the following laboratory values at study entry. All screening labs should be performed within 14 days prior to registration for protocol therapy.
Hematopoietic:
- Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
Renal:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or measured or calculated creatinine clearance (estimated by Cockcroft-Gault formula below or measured) ≥ 50 mL/min
Hepatic:
- Serum total bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 3 × ULN, unless evidence of liver metastases, then AST/ALT ≤ 5 x ULN
- Conditions
- Colorectal Cancer
- Being tested
- Pembrolizumab, mFOLFOX6
- Keywords
- Pembrolizumab, MK-3475
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6Drug
mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
- Oxaliplatin 85 mg/m^2 IV with
- Leucovorin 400 mg/m^2 IV followed by
- 5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab (MK-3475) + mFOLFOX6 | Experimental | Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks) Receives: Drug: Pembrolizumab; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival (mPFS)
Determine if pembrolizumab (MK-3475) in combination with chemotherapy improves median progression free survival (mPFS) compared to historical standards.
Response Criteria - Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Measured: From time of registration to the time of documented progression per RECIST 1.1 or subject death (estimate 14 months)
Secondary outcomes (4)
Disease Assessment for Objective Response Rate (ORR)
To determine the number of patients who achieve complete response and partial response per irRC criteria.
Measured: Begin C1D1 and every 8 weeks thereafter (up to 24 months)
Disease Assessment for Disease Control Rate
Disease control rate (DCR), defined as the sum of subjects with complete response, partial response and stable disease per RECIST 1.1 criteria.
Measured: Begin C1D1 and every 8 weeks thereafter (up to 24 months) per RECIST 1.1 criteria
Overall Survival (OS)
Overall Survival (OS) reported as number of subject alive at a median followup time of 19.9 months.
Measured: Subject should be followed from time of registration till the time of subject death up to a maximum 35.5 months
Number of Patients With Grade 3 or Higher Treatment Related Adverse Event
To assess safety and tolerability of mFOLFOX6 and pembrolizumab (MK-3475) combination chemotherapy in patients with advanced colorectal cancer per CTCAE v4.0.
Events are considered related if they assessed possible, probable or definite with study drug.
Measured: Begin C1D1 and very 2 weeks (Day 1) for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start28 May 2015
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
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.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Kathy Miller, MD, Hoosier Cancer Research Network
- Investigators
- Safi Shahda, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375672
- Sponsor's protocol ID
- HCRN GI14-186
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2015
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single Arm, Phase II Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer: HCRN GI14-186
- ClinicalTrials.gov ID
- NCT02375672
- Acronym / sponsor ID
- HCRN GI14-186
- Conditions
- Colorectal Cancer
- Keywords
- Pembrolizumab, MK-3475
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 May 2015 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 8 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-institutional, single arm, open-label, phase II study, including a safety run-in cohort. No randomization or blinding involved.
Detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
- Oxaliplatin 85 mg/m2 IV with
- Leucovorin 400 mg/m2 IV followed by
- 5FU 400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion
Pembrolizumab (MK-3475) IV over 30 minutes every 3 weeks
SAFETY RUN-IN COHORT:
The safety run-in cohort will include 6 subjects treated with 200 mg (fixed) IV infusion of pembrolizumab (MK-3475) every 3 weeks plus standard-dose mFOLFOX6 given every 2 weeks. These first 6 subjects will be followed for 4 weeks for dose limiting toxicities (DLT) before enrolling an additional 24 patients. If a DLT is observed in no more than 1 of 6 subjects, the trial will continue with enrolling subjects to the remainder of the phase II portion of the study. Otherwise, 6 additional subjects will be enrolled at dose level -1. If no more than one DLT is observed, then phase II will enroll subjects at dose level -1 for the total expected number of accrual.
Disease evaluation every 8 weeks or after every 2 cycles
Demonstrate adequate organ function as defined by the following laboratory values at study entry. All screening labs should be performed within 14 days prior to registration for protocol therapy.
Hematopoietic:
- Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
Renal:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or measured or calculated creatinine clearance (estimated by Cockcroft-Gault formula below or measured) ≥ 50 mL/min
Hepatic:
- Serum total bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 3 × ULN, unless evidence of liver metastases, then AST/ALT ≤ 5 x ULN
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab (MK-3475) + mFOLFOX6 | Experimental | Drug: Pembrolizumab, Drug: mFOLFOX6Following the safety run-in cohort: mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing and able to provide written informed consent for the trial and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Be ≥ 18 years of age on day of signing informed consent.
- Have a performance status of 0 or 1 on the ECOG Performance Scale within 14 days prior to registration.
- Have histological or cytological evidence of colorectal adenocarcinoma with confirmation of metastatic disease either by pathologic or radiologic findings.
- Have identified tissue from an archival tissue sample (preferably from a metastasis, but sample from primary tumor allowable) or newly obtained core or excisional biopsy of a tumor lesion.
Key exclusion criteria (24 listed)
- Has clearly resectable colon cancer liver metastases (CCLM), for example oligometastatic disease involving only one lobe of the liver. Subjects with suspected resectable CCLM should undergo evaluation by a liver surgeon prior to enrollment to document the incurable nature of their disease.
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of registration. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol.
- Is unable to receive a port or peripherally inserted central catheter (PICC).
- Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
- Has previously undergone organ or bone marrow transplantation and is on immunosuppressive therapy
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 |
|---|---|---|
| PembrolizumabAlso: MK-3475Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks | Drug | Pembrolizumab (MK-3475) + mFOLFOX6 |
| mFOLFOX6mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days) * Oxaliplatin 85 mg/m^2 IV with * Leucovorin 400 mg/m^2 IV followed by * 5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion | Drug | Pembrolizumab (MK-3475) + mFOLFOX6 |
Primary outcome
Median Progression Free Survival (mPFS)
Time frame: From time of registration to the time of documented progression per RECIST 1.1 or subject death (estimate 14 months)
Determine if pembrolizumab (MK-3475) in combination with chemotherapy improves median progression free survival (mPFS) compared to historical standards. Response Criteria - Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
4 secondary outcomes
Disease Assessment for Objective Response Rate (ORR)
Time frame: Begin C1D1 and every 8 weeks thereafter (up to 24 months)
Disease Assessment for Disease Control Rate
Time frame: Begin C1D1 and every 8 weeks thereafter (up to 24 months) per RECIST 1.1 criteria
Overall Survival (OS)
Time frame: Subject should be followed from time of registration till the time of subject death up to a maximum 35.5 months
Number of Patients With Grade 3 or Higher Treatment Related Adverse Event
Time frame: Begin C1D1 and very 2 weeks (Day 1) for up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Safi Shahda, M.D. study chair
Hoosier Cancer Research Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and mFOLFOX6 in people with Colorectal Cancer, run by Hoosier Cancer Research Network at 3 sites 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 24 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2021). 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?
Median Progression Free Survival (mPFS) (time frame: From time of registration to the time of documented progression per RECIST 1.1 or subject death (estimate 14 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.