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Advanced Colorectal CancerPhase 2NCT02227667

Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer

A Phase 2 study testing MEDI4736 in people with Advanced Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the patient and cancer. MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the body that help fight infections and possibly cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
MEDI4736
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
2 Dec 2014to 29 Jun 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

  • Written informed consent obtained.
  • Histologically- or cytologically- confirmed CRC.
  • Microsatelite-high colorectal cancer (also known as MSI-H, DNA mismatch repair deficient, or sometimes Lynch syndrome); or increased Tumor-Infiltrating Lymphocytes in an archived tumor specimen or fresh biopsy.
  • Locally advanced or metastatic CRC
  • Subjects have received two or more standard available therapies known to prolong survival and for which they would be considered eligible. At a minimum, such therapies should include regimens containing oxaliplatin and irinotecan in combination with a fluoropyrimidine (e.g., FOLFOX and FOLFIRI or their variants).
  • Age ≥ 18 years at time of study entry.
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  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1,500/mm3.
  • Platelet count ≥ 90,000/mm3.
  • AST and ALT ≤ 3 × institutional upper limit of normal (ULN) or ≤ 5 × ULN for subjects with liver metastases.
  • Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN for subjects with documented/suspected Gilbert's disease.
  • Serum creatinine ≤ 1.5 x ULN;
  • Radiographically measurable disease per RECIST 1.1.
  • Life expectancy ≥ 16 weeks.
  • Willingness to provide consent for use of archived tissue for research purposes.
  • Subjects will be required to agree to a biopsy performed at baseline and again at week 8 of the study in order to be eligible for enrollment in stage 1 of the study
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
  • Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
  • Subjects must use 2 acceptable methods of effective contraception as described in below.
  • Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 90 days after receipt of the final dose of investigational product.

Who cannot join

  • Anticancer therapy, monoclonal antibody or major surgery within 4 weeks prior to the first dose of MEDI4736.
  • Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  • Any prior Grade ≥ 3 irAE while receiving immunotherapy (including anti-CTLA-4 or anti-CD137 MAb) or any unresolved irAE of any grade (controlled irAE endocrinopathies are allowed).
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
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  • Active autoimmune disease within the past 2 years, except for mild conditions not requiring systemic treatment, such as vitiligo.
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. NOTE: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., by local ablation, surgery or radiotherapy).
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, irritable bowel syndrome, ulcerative colitis).
  • Receipt of radiation therapy within 4 weeks prior to starting investigational product, or limited field of radiation for palliation within 2 weeks of the first dose of investigational product.
  • Known allergy or reaction to any component of the MEDI4736 formulation or its excipients.
  • Known central nervous system (CNS) metastases requiring treatment, such as surgery, radiation or steroids.
  • Known history of confirmed primary immunodeficiency.
  • History of organ transplant requiring therapeutic immunosuppression.
  • Other malignancy within 3 years, except for noninvasive malignancies such as cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that has/have been surgically cured, or prior malignancy considered by the investigator to be of low likelihood for recurrence.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.
  • Women who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
  • Any other condition(s) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
  • Subjects who are known to be HIV positive.
  • Receipt of live attenuated vaccination within 30 days prior to receiving MEDI4736

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Study to Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer

The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the patient and cancer.

MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the body that help fight infections and possibly cancer. MEDI4736 is a special type of an antibody produced in a laboratory. MEDI4736 works by blocking a specific protein called the Programmed Death Ligand-1 (PDL-1), located on tumor cells.

Being tested
MEDI4736
Keywords
MEDI4736, 14-109

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI4736Drug

    Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.

Study groups in NCT02227667
Study groupRoleWhat they receive
Patients with Advanced Colorectal CancerExperimentalThis will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
Receives: Drug: MEDI4736

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Response Rate

    according to RECIST 1.1.

    Measured: 2 years

Secondary outcomes (1)

  1. Number of Participants Evaluated for Toxicities to Determine Safety

    Subjects will be evaluated for occurrence of AEs at each visit. Events will be characterized and reported. Safety will also be monitored by performing physical exams and routine laboratory procedures. Terminology Criteria for Adverse Events" V4.0 (CTCAE).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study start2 Dec 2014
  3. Primary completion29 Jun 2020
  4. Study completion29 Jun 2020

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227667
Sponsor's protocol ID
14-109
Status last verified
May 2021
First submitted
17 Jul 2014
Last updated
18 Jun 2021

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI4736 in people with Advanced Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center 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 21 inclusion and 20 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 18 Jun 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 18 Jun 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?

Best Response Rate (time frame: 2 years). 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 NCT02227667.

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 18 Jun 2021.

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