Last reviewed · How we verify
NCT03589651
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
Phase 1 trial testing Retifanlimab in Unresectable or Metastatic Solid Tumors in 83 participants. Completed in 21 November 2022.
21 November 2022
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 17 August 2018 |
| Primary completion | 21 November 2022 |
| Estimated completion | 21 November 2022 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Retifanlimab (RETIFANLIMAB) — full drug profile →
- Epacadostat — full drug profile →
- INCB050465 — full drug profile →
Conditions studied
- Unresectable or Metastatic Solid Tumors — all drugs for Unresectable or Metastatic Solid Tumors →
Sponsor
Incyte Corporation — full company profile →
Who can join
18 and older, any sex, with Unresectable or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x -
PI3K inhibitors are finally coming of age.
Vanhaesebroeck B, Perry MWD, Brown JR, André F, et al · · 2021 · cited 353× · PMID 34127844 · DOI 10.1038/s41573-021-00209-1 -
Targeting Tryptophan Catabolism in Cancer Immunotherapy Era: Challenges and Perspectives.
Peyraud F, Guegan JP, Bodet D, Cousin S, et al · · 2022 · cited 94× · PMID 35173722 · DOI 10.3389/fimmu.2022.807271 -
Targeting Indoleamine Dioxygenase and Tryptophan Dioxygenase in Cancer Immunotherapy: Clinical Progress and Challenges.
Peng X, Zhao Z, Liu L, Bai L, et al · · 2022 · cited 38× · PMID 35965963 · DOI 10.2147/dddt.s373780 -
Enhanced antitumor immunity through sequential targeting of PI3Kδ and LAG3.
Lauder SN, Smart K, Kersemans V, Allen D, et al · · 2020 · cited 34× · PMID 33093155 · DOI 10.1136/jitc-2020-000693 -
Strategies to Overcome Failures in T-Cell Immunotherapies by Targeting PI3K-δ and -γ.
Chandrasekaran S, Funk CR, Kleber T, Paulos CM, et al · · 2021 · cited 27× · PMID 34512641 · DOI 10.3389/fimmu.2021.718621 -
Targeting T-cell metabolism to boost immune checkpoint inhibitor therapy.
Li H, Zhao A, Li M, Shi L, et al · · 2022 · cited 22× · PMID 36569893 · DOI 10.3389/fimmu.2022.1046755 -
Immune profiling and immunotherapeutic targets in pancreatic cancer.
Lenzo FL, Kato S, Pabla S, DePietro P, et al · · 2021 · cited 18× · PMID 33569421 · DOI 10.21037/atm-20-1076
Verify or expand the search:
- PubMed search for NCT03589651
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Retifanlimab
Trials testing the same drug.
- NCT07468136 — Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas · Phase 1, PHASE2 · not yet recruiting
- NCT06896188 — 9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLE · Phase 1 · recruiting
- NCT06959537 — A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifan · Phase 1 · recruiting
- NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) · Phase 1, PHASE2 · terminated
- NCT06873789 — A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · active not recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
- NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · 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 NCT03589651 (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 Incyte Corporation
- Last refreshed: 21 February 2023
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/NCT03589651.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing