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Trial record 18 of 176 for:    immunotherapeutic agent | colon cancer

iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03867799
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : June 13, 2019
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
This is a single-arm, single centre open-label, phase II interventional clinical trial of combination immunotherapy with Nivolumab and Relatlimab in mCRC.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Nivolumab Phase 2

Detailed Description:

This is a single-arm, single centre open-label, phase II interventional clinical trial of combination immunotherapy with Nivolumab and Relatlimab in mCRC.

Participants with metastatic RAS/RAF WT colorectal cancer who have previously had a radiological response to standard first line therapy with FOLFIRI and Cetuximab but subsequently experienced progression of their disease will be eligible for the study. They will consent to the study within 4 weeks of having progressed/ become refractory to FOLFIRI and Cetuximab and undergo a mandatory baseline biopsy within this time period.

Participants will receive Nivolumab and Relatlimab every 4 weeks. After starting on the study drugs, there will be a mandatory 'on-treatment' biopsy at day 21 ± 3 days. Response assessments in the form of either CT or MRI scans will take place every 8 weeks throughout the study for the 12 months and every 12 weeks from 12 months onwards. Participants will continue on the study until progressive disease (PD) is confirmed by RECIST 1.1 or when maximum duration of treatment of 24 months has been reached.

There will be the possibility of 'treating beyond progression' if participants are deriving clinical benefit from treatment to encompass the possibility of pseudoprogression. At PD participants will undergo a further biopsy. The investigators envisage enrolling a total of 25 participants and the investigators anticipate 30 months as a feasible time frame for accrual.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy Sequencing in COlon and REctal Cancer
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab and Relatlimab
Nivolumab 480mg and Relatlimab 160mg will be administered intravenously every 4 weeks
Drug: Nivolumab
Other Name: Relatlimab

Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 6 months from treatment initiation ]

Secondary Outcome Measures :
  1. NCI CTCAE version 5.0 toxicity [ Time Frame: within 30 days of the last dose of study treatment ]
  2. Disease Control Rate (DCR) [ Time Frame: 12 and 24 months ]
  3. Duration of disease control [ Time Frame: 6, 12 and 24 months ]
  4. Best Objective Response Rate [ Time Frame: 6, 12 and 24 months ]
  5. Progression Free Survival [ Time Frame: Time from registration to progression (radiological or clinical) or death at 6 months, 12 months and 24 months ]
  6. Overall survival [ Time Frame: time from registration to death from any cause at 6 months, 12 months and 24 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female patients aged ≥18 years
  • Patients with histologically confirmed advanced/metastatic RAS/RAF wild type colon or rectal adenocarcinoma who had a prior radiological response to first line treatment with FOLFIRI and Cetuximab but have subsequently progressed/ become refractory to this treatment based on physician judgment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Estimated life expectancy of at least 3 months at the time of informed consent per Investigator assessment
  • Adequate organ functioning including haematological, renal, liver and cardiac function
  • Negative serum or urine pregnancy test at screening for women of childbearing potential and use of highly effective contraception for both male and female patients throughout the study
  • Patient must consent and be eligible to undergo mandatory baseline and sequential biopsies
  • Presence of measurable disease as defined by RECIST v 1.1 criteria for response assessment

Exclusion Criteria:

  • Systemic therapy within 4 weeks prior to the planned administration of the first study treatment dose
  • Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 48 hours prior to study entry and there is at least one measurable lesion that has not been irradiated.
  • Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs
  • Uncontrolled or significant cardiovascular disease including including patients with a history of myocarditis, regardless of aetiology
  • Known severe hypersensitivity reactions (Grade ≥ 3 NCI CTCAE v 5.0) to monoclonal antibodies or related compounds or any of their components
  • Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
  • Active, known or suspected autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with type I diabetes mellitis, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis
  • Pregnancy or lactation
  • Vaccination within 4 weeks of the first dose of study drugs and while on trial is prohibited except for administration of inactivated vaccines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03867799

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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Richard Crux    02086613807   
Sub-Investigator: Fiona Turkes         
Principal Investigator: Naureen Starling         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT03867799     History of Changes
Other Study ID Numbers: CCR4938
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases