18 and older, any sex, with Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Objective Response Rate (ORR) of Dual Immune Checkpoint Blockade by RECIST 1.1Primary· Through treatment, up to 1.3 years
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be \<10mm on the short axis.
Partial Response (PR): 30% or more decrease in the sum of diameters of target lesions. The reference the baseline sums of diameters. Progressive Disease (PD): 20% or more increase in the sum of diameters of target lesions. The reference is the smallest sum while on study (including the baseline sum if that is the smallest on study). In addition to the relative 20% increase, the sum must also demonstrate an absolute increase 5mm or more. (No
Group
Value
95% CI
Durvalumab and Tremelimumab
9.52
1.17 – 30.38
Percentage of Patients Who Have Achieved Clinical BenefitSecondary· At 16 weeks
Percentage of patients who have achieved clinical benefit defined as CR (complete response) and PR (partial response) and stable disease that lasts at least 4 months
Group
Value
95% CI
Durvalumab and Tremelimumab
14.29
3.05 – 36.34
Median Duration of Response to mCRC (Metastic Colorectal Cancer) Responds to Study TherapySecondary· Through study completetion (1.3 years)
Median time from study entry until documentation of progression (years) in half of the patients as determined by RECIST 1.1.
Group
Value
95% CI
Durvalumab and Tremelimumab
0.85
0 – NA
Frequency of Adverse Events Assessed by CTCAE 4.0, From Beginning of Treatment to 90 Days After Last DoseSecondary· During treatment (max of 12 cycles; each cycle 28 days) to 90 days after last dose of study therapy
Frequency of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0
Total
Group
Value
95% CI
Durvalumab and Tremelimumab
29
Grade 0
Group
Value
95% CI
Durvalumab and Tremelimumab
2
Grade 1
Group
Value
95% CI
Durvalumab and Tremelimumab
3
Grade 2
Group
Value
95% CI
Durvalumab and Tremelimumab
6
Grade 3
Group
Value
95% CI
Durvalumab and Tremelimumab
14
Grade 4
Group
Value
95% CI
Durvalumab and Tremelimumab
3
Grade 5
Group
Value
95% CI
Durvalumab and Tremelimumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study therapy until 90 days after the last dose of study therapy..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells.
In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06694454 — Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immun
· Phase 1, PHASE2
· not yet recruiting
NCT05924880 — A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatm
· Phase 3
· completed
NCT05683977 — A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Ce
· active not recruiting
NCT05298423 — Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizuma
· Phase 3
· active not recruiting
NCT05043090 — Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced
· Phase 3
· active not recruiting
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Trials by the same sponsor.
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· Phase 2
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NSABP Foundation Inc
Last refreshed: 5 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03007407.