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Trial record 6 of 367 for:    colorectal | Recruiting Studies | United States

Tremelimumab (Anti-CTLA-4) Plus MEDI4736 (Anti-PD-L1) in Resectable Colorectal Cancer Liver Metastases

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02754856
First received: April 26, 2016
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
The goal of this clinical research study is to learn if tremelimumab in combination with MEDI4736 can help to control colorectal cancer that has spread to the liver. The safety of these drugs will also be studied.

Condition Intervention Phase
Colorectal Cancer Liver Metastases Drug: Tremelimumab Drug: MEDI4736 Procedure: Liver Resection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus MEDI4736 (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Tremelimumab plus MEDI4736 with FOLFOX and Bevacizumab in Candidates for Resection of Colorectal Cancer Liver Metastases [ Time Frame: 15 weeks ]
    Feasibility assessed by whether or not the patient successfully goes to surgery following the planned treatments, scans, and biopsy. Combination regimen considered feasible if at least 80% of patients successfully undergo surgery. It will be infeasible if fewer than 60% of patients can undergo surgery.


Secondary Outcome Measures:
  • Relapse-free survival (RFS) of Tremelimumab plus MEDI4736 with FOLFOX and Bevacizumab in Candidates for Resection of Colorectal Cancer Liver Metastases [ Time Frame: 56 weeks ]
    Relapse-free survival (RFS) assessed from the date of study entry until relapse or death from any cause.


Estimated Enrollment: 35
Actual Study Start Date: July 28, 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tremelimumab + MEDI4736

Participants receive Tremelimumab by vein over about 1 hour and MEDI4736 by vein over about 4 hours during Week 11. After Week 11, participants receives MEDI4736 alone by vein over about 1 hour during Weeks 21, 25, 29, and 33.

Between Weeks 15 and 17, participant undergoes scheduled liver surgery.

Drug: Tremelimumab
Tremelimumab 75 mg by vein as a flat dose during Week 11.
Drug: MEDI4736
MEDI4736 1500 mg by vein as a flat dose during Week 11. After Week 11, participant receives MEDI4736 alone by vein during Weeks 21, 25, 29, and 33.
Other Name: Durvalumab
Procedure: Liver Resection
Participant undergoes scheduled liver resection between Weeks 15 and 17.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed colorectal cancer with metastases deemed resectable by a general or liver surgeon (resectability may involve the use of ablative techniques to some but not all liver metastases). Those patients with known disease outside of the liver are not eligible (except for patients with primary lesions in place that are planned for resection or nonspecific lung metastases <1cm).
  2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>10 mm with spiral CT scan.
  3. All lines of prior therapy accepted. Subjects with prior hepatic or extra-hepatic resections of metastatic disease will be included.
  4. Age =/>18 years. Because no dosing or adverse event data are currently available on the use of tremelimumab in combination with MEDI4736 in patients <18 years of age, children are excluded from this study.
  5. Life expectancy of greater than 6 months.
  6. ECOG performance status =/<1 (Karnofsky =/>70%).
  7. Patients must have normal organ and marrow function as defined: a) leukocytes =/>3,000/mcL; b) absolute neutrophil count =/>1,500/mcL; c) platelets =/>100,000/mcL; d) total bilirubin < 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL); e) AST(SGOT)/ALT(SGPT) =/< 3 X institutional upper limit of normal; f) creatinine within normal institutional limits OR g) creatinine clearance =/>60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  8. Known or ordered molecular testing for MSI, BRAF, and KRAS status.
  9. The effects of tremelimumab and/or MEDI4736 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because immune checkpoint inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 180 days after the last dose of tremelimumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Prior chemotherapy < 2 weeks prior to study drug treatment and treatment related adverse events that have not recovered to baseline or grade 1 (alopecia excluded). Prior radiation therapy <4weeks prior to study drug treatment.
  2. Patients may not be receiving any other investigational agents.
  3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: a) Patients with vitiligo or alopecia; b) Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; c) Any chronic skin condition that does not require systemic therapy; d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
  4. Subjects with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  5. Prior exposure to T cell checkpoint inhibitor therapies.
  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. Positive test for hepatitis B virus surface antigen or hepatitis C (IgG or RNA test) indicating acute or chronic infection.
  8. Positive test for HIV.
  9. Women who are pregnant, which includes women with a positive pregnancy test at enrollment or prior to the administration of study medication, or breastfeeding are not allowed on study.
  10. Receipt of a live vaccine within 30 days of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02754856

Contacts
Contact: Michael Overman, MD 713-792-2828

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
MedImmune LLC
Investigators
Principal Investigator: Michael Overman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02754856     History of Changes
Other Study ID Numbers: 2015-0828
NCI-2016-00772 ( Registry Identifier: NCI CTRP )
Study First Received: April 26, 2016
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
Liver Metastases
Resectable liver metastases
Tremelimumab
Fluorouracil
5-Fluorouracil
5-FU
Adrucil
Efudex
Leucovorin
Citrovorum
Wellcovorin
Oxaliplatin
Eloxatin
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
MEDI4736
Durvalumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Liver Extracts
Fluorouracil
Tremelimumab
Antibodies, Monoclonal
Hematinics
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017