NCT03291054 is a Phase 2 clinical trial of Pembrolizumab in Gastrointestinal Stromal Tumors, sponsored by Columbia University.

Who is sponsoring NCT03291054?

NCT03291054 is sponsored by Columbia University.

What drugs are being tested in NCT03291054?

Interventions in NCT03291054: Pembrolizumab, Epacadostat.

What condition does NCT03291054 study?

NCT03291054 studies Gastrointestinal Stromal Tumors.

Is NCT03291054 still recruiting?

NCT03291054 is currently terminated. Last updated 11 June 2024.

Are results published for NCT03291054?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-11 · How we verify

NCT03291054

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

Epacadostat and Pembrolizumab in Patients With GIST

Terminated Phase 2 Results posted Last updated 11 June 2024

What this trial tests

Phase 2 trial testing Pembrolizumab in Gastrointestinal Stromal Tumors in 1 participant. Terminated before completion.

Timeline

28 February 2018

Primary endpoint
19 August 2020

19 August 2020

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	28 February 2018
Primary completion	19 August 2020
Estimated completion	19 August 2020
Sites	2 locations across United States

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Epacadostat — full drug profile →

Conditions studied

Gastrointestinal Stromal Tumors — all drugs for Gastrointestinal Stromal Tumors →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary objective is to assess the efficacy of combined Indoleamine 2,3-dioxygenase (IDO) and PD-1 inhibition in a single arm phase II trial of epacadostat and pembrolizumab in patients with advanced imatinib-refractory GIST, using a primary endpoint of overall response rate. Secondary objectives are to evaluate the progression free survival (PFS), the overall survival (OS), the response rate and to evaluate the safety and tolerability of combined epacadostat and pembrolizumab treatment. The investigator hypothesizes that treatment with epacadostat and pembrolizumab will increase the response rate compared to what has been historically achieved with salvage tyrosine kinase inhibitors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
The Role of Indoleamine-2,3-Dioxygenase in Cancer Development, Diagnostics, and Therapy.
Hornyák L, Dobos N, Koncz G, Karányi Z, et al · · 2018 · cited 243× · PMID 29445380 · DOI 10.3389/fimmu.2018.00151
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
Metabolism in tumor microenvironment: Implications for cancer immunotherapy.
Shi R, Tang YQ, Miao H. · · 2020 · cited 131× · PMID 34766109 · DOI 10.1002/mco2.6
Molecular mechanisms and therapeutic significance of Tryptophan Metabolism and signaling in cancer.
Yan J, Chen D, Ye Z, Zhu X, et al · · 2024 · cited 91× · PMID 39472902 · DOI 10.1186/s12943-024-02164-y
Next generation immune-checkpoints for cancer therapy.
Donini C, D'Ambrosio L, Grignani G, Aglietta M, et al · · 2018 · cited 50× · PMID 29951308 · DOI 10.21037/jtd.2018.02.79
Metabolic regulation of myeloid-derived suppressor cells in tumor immune microenvironment: targets and therapeutic strategies.
Wang H, Zhou F, Qin W, Yang Y, et al · · 2025 · cited 45× · PMID 39990210 · DOI 10.7150/thno.105276
Gastrointestinal Stromal Tumors (GISTs): Novel Therapeutic Strategies with Immunotherapy and Small Molecules.
Vallilas C, Sarantis P, Kyriazoglou A, Koustas E, et al · · 2021 · cited 41× · PMID 33419029 · DOI 10.3390/ijms22020493

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Gastrointestinal Stromal Tumors

Currently open trials in the same condition.

NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres · Phase 1 · recruiting
NCT06326346 — GIST Oral Paclitaxel(Liporaxel) · Phase 2 · recruiting
NCT06087263 — Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation · Phase 2 · active not recruiting
NCT05366816 — ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST · Phase 2 · recruiting
NCT05905887 — Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor · Phase 2 · recruiting

Other Columbia University trials

Trials by the same sponsor.

NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
NCT07403604 — Effect of Insulin Lowering on Lipogenesis · 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 NCT03291054 (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 Columbia University
Last refreshed: 11 June 2024

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/NCT03291054.

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