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An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Program Status

Completed

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Ipilimumab, Nivolumab, Regorafenib, Trametinib, Mekinist, Opdivo, Yervoy

Tags

MSS/ MMRp

Comments

Doublet arm: nivolumbab/Opdivo + trametinib/Mekinist [anti-PD-1 + MEKi // similar to the known ”atezo + cobi”, atezolizumab + cobimetinib combination, that did not result for MSS CRC]
Triplet arm: nivolumbab/Opdivo + trametinib/Mekinist + ipilimumab/Yervoy [anti-PD-1 + MEKi + anti CTLA-4]
Key exclusion criteria: BRAF V600 mutant colorectal cancer, prior treatment with MEKi

Location	Location Status
United States
Local Institution - 0022 Birmingham, Alabama 35249	Completed
Local Institution - 0027 Los Angeles, California 90033	Completed
Local Institution - 0067 Los Angeles, California 90089	Completed
Local Institution - 0001 San Francisco, California 94158	Completed
Local Institution - 0107 Gainesville, Florida 32610	Completed
Local Institution - 0111 Miami, Florida 33136	Completed
Local Institution - 0028 Baltimore, Maryland 21287	Completed
Local Institution - 0116 Hattiesburg, Mississippi 39401-7233	Completed
Local Institution - 0103 Saint Louis, Missouri 63110	Completed
Local Institution - 0104 New York, New York 10016	Completed
Local Institution - 0029 Charlotte, North Carolina 28204	Completed
Local Institution - 0100 Lancaster, Pennsylvania 17604	Completed
Local Institution - 0003 Philadelphia, Pennsylvania 19104	Completed
Thomas Jefferson University - Clinical Research Institute Philadelphia, Pennsylvania 19107	Completed
Local Institution - 0101 Temple, Texas 76508	Completed
Local Institution - 0002 Madison, Wisconsin 53792-0001	Completed
Argentina
Local Institution - 0120 Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ	Completed
Local Institution - 0122 Buenos Aires, Distrito Federal C1096AAS	Completed
Local Institution - 0123 Ciudad Autónoma de Buenos Aires, Distrito Federal 1181	Completed
Local Institution - 0119 Buenos Aires 1431	Completed
Australia
Local Institution - 0044 Blacktown, New South Wales 2148	Completed
Local Institution - 0043 Southport, Queensland 4215	Completed
Local Institution - 0068 Elizabeth Vale, South Australia 05112	Completed
Local Institution - 0055 Clayton, Victoria 0	Completed
Local Institution - 0069 Heidelberg, Victoria 3084	Completed
Belgium
Local Institution Woluwe-Saint-Lambert 1200	Completed
Canada
Local Institution - 0113 Edmonton, Alberta T6G 1Z2	Completed
Local Institution - 0070 Toronto, Ontario M5G 2M9	Completed
Local Institution - 0077 Montréal, Quebec H2X 0A9	Completed
Local Institution - 0076 Ottawa K1H 8L6	Completed
Chile
Local Institution - 0117 Santiago, Metropolitana 000000	Completed
Local Institution - 0118 Santiago, Región Metropolitana De Santiago 8420383	Completed
Czechia
Local Institution - 0072 Olomouc, Olomoucký Kraj 779 00	Completed
Local Institution - 0071 Brno 65653	Completed
Local Institution - 0073 Hradec Kralove 500 05	Completed
Germany
Local Institution - 0004 Hannover 30625	Completed
Italy
Local Institution - 0095 Catania 95124	Completed
Local Institution - 0093 Milan 20133	Completed
Local Institution - 0092 Padova 35128	Completed
Local Institution - 0094 Rozzano 20089	Completed
Spain
Local Institution - 0079 Badalona, Barcelona [Barcelona] 08916	Completed
Local Institution - 0080 Pamplona, Navarra 31009	Completed
Local Institution - 0052 Barcelona 08035	Completed
Local Institution - 0114 Madrid 28007	Completed
Local Institution - 0051 Madrid 28041	Completed
Local Institution - 0115 Madrid 28050	Completed
Local Institution - 0096 Sevilla 41013	Completed

Inclusion Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
* Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
* Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)

Exclusion Criteria

Exclusion Criteria:

* BRAF V600 mutant colorectal cancer
* Active brain metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* History of interstitial lung disease or pneumonitis
* Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
* History of allergy or hypersensitivity to study drug components

Other protocol defined inclusion/exclusion criteria apply

NCT ID

NCT03377361

Date Trial Added

2017-12-19

Updated Date

2024-12-11