NCT03158064 is a Phase 2 clinical trial of Durvalumab in Germ Cell Tumor, sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT03158064?

NCT03158064 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT03158064?

Interventions in NCT03158064: Durvalumab, Tremelimumab.

What condition does NCT03158064 study?

NCT03158064 studies Germ Cell Tumor, Nonseminomatous Germ Cell Tumor, Seminoma, Germinomatous Germ Cell Tumor, Dysgerminoma, Pineal Germ Cell Tumor.

Is NCT03158064 still recruiting?

NCT03158064 is currently active, enrolled. Last updated 26 January 2026.

Last reviewed 2026-01-26 · How we verify

NCT03158064

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

A Single-arm, Phase II Study of Durvalumab (MEDI4736) and Tremelimumab for Relapsed/Refractory Germ Cell Tumors

Active, enrolled Phase 2 Last updated 26 January 2026

What this trial tests

Phase 2 trial testing Durvalumab in Germ Cell Tumor in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 May 2017

Primary endpoint
1 November 2026

1 November 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 May 2017
Primary completion	1 November 2026
Estimated completion	1 November 2026
Sites	7 locations across United States

Drugs / interventions tested

Durvalumab — full drug profile →
Tremelimumab (TREMELIMUMAB) — full drug profile →

Conditions studied

Germ Cell Tumor — all drugs for Germ Cell Tumor →
Nonseminomatous Germ Cell Tumor — all drugs for Nonseminomatous Germ Cell Tumor →
Seminoma — all drugs for Seminoma →
Germinomatous Germ Cell Tumor — all drugs for Germinomatous Germ Cell Tumor →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Germ Cell Tumor or Nonseminomatous Germ Cell Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

overall response rate (ORR)
Time frame: 1 year
by RECIST v1.1

Sponsor's own description

The purpose of this study is to test the safety and effectiveness of durvalumab with tremelimumab in patients with relapsed or refractory germ cell tumors.

Publications & conference data

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

Non-Epithelial Ovarian Cancers: How Much Do We Really Know?
Cheung A, Shah S, Parker J, Soor P, et al · · 2022 · cited 63× · PMID 35162125 · DOI 10.3390/ijerph19031106
Immunotherapy in Testicular Germ Cell Tumors.
Kalavska K, Schmidtova S, Chovanec M, Mego M. · · 2020 · cited 40× · PMID 33072608 · DOI 10.3389/fonc.2020.573977
Overcoming Chemotherapy Resistance in Germ Cell Tumors.
Országhová Z, Kalavska K, Mego M, Chovanec M. · · 2022 · cited 27× · PMID 35625709 · DOI 10.3390/biomedicines10050972
Molecular Pathways and Targeted Therapies for Malignant Ovarian Germ Cell Tumors and Sex Cord-Stromal Tumors: A Contemporary Review.
Maoz A, Matsuo K, Ciccone MA, Matsuzaki S, et al · · 2020 · cited 26× · PMID 32485873 · DOI 10.3390/cancers12061398
Recent advances in testicular germ cell tumours.
Mele T, Reid A, Huddart R. · · 2021 · cited 10× · PMID 34557871 · DOI 10.12703/r/10-67
SWOG/NCI Phase II Dual Anti-CTLA-4/PD-1 Blockade in Rare Tumors: Nonepithelial Ovarian Cancer.
Chae YK, Othus M, Patel SP, Wilkinson KJ, et al · · 2024 · cited 8× · PMID 39417692 · DOI 10.1158/1078-0432.ccr-24-0606
Systemic therapy for primary and extragonadal germ cell tumors: prognosis and nuances of treatment.
Siddiqui BA, Zhang M, Pisters LL, Tu SM. · · 2020 · cited 8× · PMID 32055486 · DOI 10.21037/tau.2019.09.11
Establishment and characterisation of testicular cancer patient-derived xenograft models for preclinical evaluation of novel therapeutic strategies.
de Vries G, Rosas-Plaza X, Meersma GJ, Leeuwenburgh VC, et al · · 2020 · cited 5× · PMID 33144587 · DOI 10.1038/s41598-020-75518-3

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
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 Germ Cell Tumor

Currently open trials in the same condition.

NCT06418789 — High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors · Phase 2 · recruiting
NCT06133543 — Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer · NA · recruiting
NCT05564026 — Molecular Epidemiology of Pediatric Germ Cell Tumors · recruiting
NCT05259605 — Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 202 · recruiting
NCT05672043 — Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · 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 NCT03158064 (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 Memorial Sloan Kettering Cancer Center
Last refreshed: 26 January 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/NCT03158064.

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