NCT03911557 is a Phase 2 clinical trial of Durvalumab and Tremelimumab in Tumor, Solid, sponsored by John L. Villano, MD, PhD.

Who is sponsoring NCT03911557?

NCT03911557 is sponsored by John L. Villano, MD, PhD.

What drugs are being tested in NCT03911557?

Interventions in NCT03911557: Durvalumab and Tremelimumab.

What condition does NCT03911557 study?

NCT03911557 studies Tumor, Solid.

Is NCT03911557 still recruiting?

NCT03911557 is currently completed. Last updated 12 November 2025.

Last reviewed 2025-11-12 · How we verify

NCT03911557

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

Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors

Completed Phase 2 Last updated 12 November 2025

What this trial tests

Phase 2 trial testing Durvalumab and Tremelimumab in Tumor, Solid in 14 participants. Completed in 10 October 2025.

Timeline

8 June 2019

Primary endpoint
10 October 2025

10 October 2025

Quick facts

Lead sponsor	John L. Villano, MD, PhD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	8 June 2019
Primary completion	10 October 2025
Estimated completion	10 October 2025
Sites	1 location across United States

Drugs / interventions tested

Durvalumab and Tremelimumab — full drug profile →

Conditions studied

Tumor, Solid — all drugs for Tumor, Solid →

Sponsor

John L. Villano, MD, PhD — full company profile →

Who can join

18 and older, any sex, with Tumor, Solid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine whether patients with relapsed/refractory solid tumors harboring evidence of somatic hypermutation (intermediate versus high tumor mutational burden) will exhibit improvement in disease progression-free survival with dual Tremelimumab and Durvalumab treatment.

Publications & conference data

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

Translating the evolving molecular landscape of tumors to biomarkers of response for cancer immunotherapy.
Anagnostou V, Landon BV, Medina JE, Forde P, et al · · 2022 · cited 38× · PMID 36350985 · DOI 10.1126/scitranslmed.abo3958
The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
The Comprehensive "Omics" Approach from Metabolomics to Advanced Omics for Development of Immune Checkpoint Inhibitors: Potential Strategies for Next Generation of Cancer Immunotherapy.
Yoon SJ, Lee CB, Chae SU, Jo SJ, et al · · 2021 · cited 13× · PMID 34203237 · DOI 10.3390/ijms22136932

Verify or expand the search:

Other trials of Durvalumab and Tremelimumab

Trials testing the same drug.

NCT04221555 — Trial of Neoadjuvant Durvalumab Plus Docetaxel, Oxaliplatin, S-1 Followed by Surgery and Adjuvant Durvalumab Plus S-1 Ch · Phase 2 · completed
NCT03385655 — Prostate Cancer Biomarker Enrichment and Treatment Selection · Phase 2 · active not recruiting
NCT03317457 — Durvalumab and Tremelimumab Compared to Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma · Phase 2 · completed
NCT02937818 — A Phase II, Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Ref · Phase 2 · completed

Other recruiting trials for Tumor, Solid

Currently open trials in the same condition.

NCT07348042 — Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radic · Phase 1 · recruiting
NCT06987500 — A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment · Phase 1, PHASE2 · recruiting
NCT06911333 — AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07433283 — Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor · Phase 1, PHASE2 · recruiting
NCT04723810 — TumorGlow Intraoperative Molecular Imaging (IMI) · Phase 1, PHASE2 · recruiting

Other John L. Villano, MD, PhD trials

Trials by the same sponsor.

NCT04964960 — Pembro+Chemo in Brain Mets · Phase 2 · terminated
NCT03313804 — Priming Immunotherapy in Advanced Disease With Radiation · Phase 2 · completed

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 NCT03911557 (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 John L. Villano, MD, PhD
Last refreshed: 12 November 2025

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/NCT03911557.

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