NCT03712943 is a Phase 1 clinical trial of Regorafenib in Colorectal Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT03712943?

NCT03712943 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT03712943?

Interventions in NCT03712943: Regorafenib, Nivolumab.

What condition does NCT03712943 study?

NCT03712943 studies Colorectal Cancer, Metastatic Colorectal Cancer, Colon Cancer.

Is NCT03712943 still recruiting?

NCT03712943 is currently completed. Last updated 9 February 2026.

Last reviewed 2026-02-09 · How we verify

NCT03712943

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer

Completed Phase 1 Last updated 9 February 2026

What this trial tests

Phase 1 trial testing Regorafenib in Colorectal Cancer in 52 participants. Completed in 18 January 2024.

Timeline

23 October 2018

Primary endpoint
1 September 2021

18 January 2024

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	23 October 2018
Primary completion	1 September 2021
Estimated completion	18 January 2024
Sites	1 location across United States

Drugs / interventions tested

Regorafenib — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Colon Cancer — all drugs for Colon Cancer →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Colorectal Cancer or Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study is to test the safety, tolerable side effects, and determine the highest tolerable dose of the combination of Regorafenib and Nivolumab. Researchers want to find out if this combination of Regorafenib and Nivolumab can help people with metastatic colorectal cancer with mismatch repair (MMR) proficiency.

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
Role of Tumor-Mediated Dendritic Cell Tolerization in Immune Evasion.
DeVito NC, Plebanek MP, Theivanthiran B, Hanks BA. · · 2019 · cited 72× · PMID 31921140 · DOI 10.3389/fimmu.2019.02876
A phase I/Ib study of regorafenib and nivolumab in mismatch repair proficient advanced refractory colorectal cancer.
Kim RD, Kovari BP, Martinez M, Xie H, et al · · 2022 · cited 69× · PMID 35526308 · DOI 10.1016/j.ejca.2022.03.026
Anti-PD-1/PD-L1 therapy for colorectal cancer: Clinical implications and future considerations.
Chen X, Chen LJ, Peng XF, Deng L, et al · · 2024 · cited 48× · PMID 38042137 · DOI 10.1016/j.tranon.2023.101851
The Interplay of Autophagy and Tumor Microenvironment in Colorectal Cancer-Ways of Enhancing Immunotherapy Action.
Koustas E, Sarantis P, Kyriakopoulou G, Papavassiliou AG, et al · · 2019 · cited 41× · PMID 31013961 · DOI 10.3390/cancers11040533
Immune Checkpoint Inhibitors in pMMR Metastatic Colorectal Cancer: A Tough Challenge.
Marmorino F, Boccaccino A, Germani MM, Falcone A, et al · · 2020 · cited 39× · PMID 32824490 · DOI 10.3390/cancers12082317
The Efficacy of Immune Checkpoint Inhibitors in Microsatellite Stable Colorectal Cancer: A Systematic Review.
Guven DC, Kavgaci G, Erul E, Syed MP, et al · · 2024 · cited 35× · PMID 38309719 · DOI 10.1093/oncolo/oyae013
Advances in immune checkpoint inhibitor combination strategies for microsatellite stable colorectal cancer.
Ros J, Balconi F, Baraibar I, Saoudi Gonzalez N, et al · · 2023 · cited 33× · PMID 36816981 · DOI 10.3389/fonc.2023.1112276

Verify or expand the search:

Other trials of Regorafenib

Trials testing the same drug.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07392866 — A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellula · Phase 2, PHASE3 · not yet recruiting
NCT06820957 — Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has S · Phase 2, PHASE3 · active not recruiting
NCT07223567 — A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cance · Phase 2 · withdrawn
NCT07134205 — The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

NCT05041335 — Wet Heparinized Suction for Abdominal Cancer · NA · not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03712943 (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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 9 February 2026

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/NCT03712943.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing