Last reviewed · How we verify
NCT02993991: PRIMED-001
Pre-operative Mocetinostat (MGCD0103) and Durvalumab (MEDI4736) (PRIMED) for Squamous Cell Carcinoma of the Oral Cavity
Phase 1 trial testing Mocetinostat in Squamous Cell Carcinoma, Head And Neck. Withdrawn.
21 December 2017
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 10 October 2017 |
| Primary completion | 21 December 2017 |
| Estimated completion | 21 December 2017 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Mocetinostat — full drug profile →
- Durvalumab — full drug profile →
Conditions studied
- Squamous Cell Carcinoma, Head And Neck — all drugs for Squamous Cell Carcinoma, Head And Neck →
- Squamous Cell Carcinoma Mouth — all drugs for Squamous Cell Carcinoma Mouth →
- Resectable Squamous Cell Carcinoma of Oral Cavity — all drugs for Resectable Squamous Cell Carcinoma of Oral Cavity →
Sponsor
University Health Network, Toronto
Who can join
18 and older, any sex, with Squamous Cell Carcinoma, Head And Neck or Squamous Cell Carcinoma Mouth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous cell carcinoma of the oral cavity.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Epi-drugs in combination with immunotherapy: a new avenue to improve anticancer efficacy.
Mazzone R, Zwergel C, Mai A, Valente S. · · 2017 · cited 113× · PMID 28572863 · DOI 10.1186/s13148-017-0358-y -
Checkpoint immunotherapy in head and neck cancers.
Zolkind P, Uppaluri R. · · 2017 · cited 36× · PMID 28836124 · DOI 10.1007/s10555-017-9694-9 -
Epi-immunotherapy for cancers: rationales of epi-drugs in combination with immunotherapy and advances in clinical trials.
Xu Y, Li P, Liu Y, Xin D, et al · · 2022 · cited 29× · PMID 35642676 · DOI 10.1002/cac2.12313 -
Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744 -
Autoimmune disease: a view of epigenetics and therapeutic targeting.
Mu S, Wang W, Liu Q, Ke N, et al · · 2024 · cited 21× · PMID 39606248 · DOI 10.3389/fimmu.2024.1482728 -
Leveraging Genomics for Head and Neck Cancer Treatment.
Kemmer JD, Johnson DE, Grandis JR. · · 2018 · cited 8× · PMID 29420101 · DOI 10.1177/0022034518756352
Verify or expand the search:
- PubMed search for NCT02993991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mocetinostat
Trials testing the same drug.
- NCT04299113 — Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma · Phase 1 · active not recruiting
- NCT02954991 — Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer · Phase 2 · terminated
Other recruiting trials for Squamous Cell Carcinoma, Head And Neck
Currently open trials in the same condition.
- NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet 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 NCT02993991 (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 University Health Network, Toronto
- Last refreshed: 29 December 2017
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/NCT02993991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing