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NCT03005002
Durvalumab and Tremelimumab in Treating Patients With Microsatellite Stable Metastatic Colorectal Cancer to the Liver
Phase 1 trial testing Durvalumab in Metastatic Carcinoma in the Liver in 9 participants. Completed in 26 November 2019.
26 November 2019
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 28 June 2017 |
| Primary completion | 26 November 2019 |
| Estimated completion | 26 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Durvalumab — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Tremelimumab (TREMELIMUMAB) — full drug profile →
Conditions studied
- Metastatic Carcinoma in the Liver — all drugs for Metastatic Carcinoma in the Liver →
- MLH1 Gene Mutation — all drugs for MLH1 Gene Mutation →
- MSH6 Gene Mutation — all drugs for MSH6 Gene Mutation →
- PMS2 Gene Mutation — all drugs for PMS2 Gene Mutation →
Sponsor
City of Hope Medical Center
Who can join
19 and older, any sex, with Metastatic Carcinoma in the Liver or MLH1 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot clinical trial studies the side effects and how well durvalumab and tremelimumab work in treating patients with microsatellite stable colorectal cancer that has spread to the liver. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
PD-1 and PD-L1 inhibitors in cold colorectal cancer: challenges and strategies.
Lin KX, Istl AC, Quan D, Skaro A, et al · · 2023 · cited 90× · PMID 37831146 · DOI 10.1007/s00262-023-03520-5 -
Is There a Place for Immunotherapy for Metastatic Microsatellite Stable Colorectal Cancer?
Ghiringhelli F, Fumet JD. · · 2019 · cited 61× · PMID 31447840 · DOI 10.3389/fimmu.2019.01816 -
Safety of selective internal radiation therapy (SIRT) with yttrium-90 microspheres combined with systemic anticancer agents: expert consensus.
Kennedy A, Brown DB, Feilchenfeldt J, Marshall J, et al · · 2017 · cited 32× · PMID 29299370 · DOI 10.21037/jgo.2017.09.10 -
A Pilot Feasibility Study of Yttrium-90 Liver Radioembolization Followed by Durvalumab and Tremelimumab in Patients with Microsatellite Stable Colorectal Cancer Liver Metastases.
Wang C, Park J, Ouyang C, Longmate JA, et al · · 2020 · cited 30× · PMID 31857446 · DOI 10.1634/theoncologist.2019-0924 -
The Emerging Role of Checkpoint Inhibition in Microsatellite Stable Colorectal Cancer.
Hermel DJ, Sigal D. · · 2019 · cited 26× · PMID 30654522 · DOI 10.3390/jpm9010005 -
Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744 -
Landscape of Immunotherapy Options for Colorectal Cancer: Current Knowledge and Future Perspectives beyond Immune Checkpoint Blockade.
Gorzo A, Galos D, Volovat SR, Lungulescu CV, et al · · 2022 · cited 21× · PMID 35207516 · DOI 10.3390/life12020229 -
Perspectives of Targeting Autophagy as an Adjuvant to Anti-PD-1/PD-L1 Therapy for Colorectal Cancer Treatment.
ALKhemeiri N, Eljack S, Saber-Ayad MM. · · 2025 · cited 5× · PMID 40422248 · DOI 10.3390/cells14100745
Verify or expand the search:
- PubMed search for NCT03005002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
- NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
Other recruiting trials for Metastatic Carcinoma in the Liver
Currently open trials in the same condition.
- NCT06860815 — Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Br · Phase 2 · recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03005002 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 City of Hope Medical Center
- Last refreshed: 26 December 2019
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/NCT03005002.
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