The GMRF Clinical Trials Unit is currently recruiting for the following clinical trials in general oncology:
PROTOCOL: V940-007 (pi: dR D. Rahul Ladwa)
Protocol Title: A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC)
Lay Title: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
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PROTOCOL: NST-628-001 (PI: Dr Victoria Atkinson) (NOT YET RECRUITING)
Protocol Title: A Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, and preliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumors harboring genetic alterations in the MAPK pathway and with other solid tumors
Lay Title: A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
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Protocol: AMT-676-01 (PI: DR Warren Joubert) (NOT YET RECRUITING)
Protocol Title: First-in-Human, Phase 1 Study of AMT-676, an Anti CDH17 Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors
PROTOCOL: BGB-A317-3111-10188-101 (PI: dR Jeffrey Goh) (PART E (OVARIAN) ONLY)
Protocol Title: A Phase 1/2, Dose Escalation and Expansion Study of BGB-10188, a Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor, Combined with Zanubrutinib in Patients with Mature B-Cell Malignancies and Combined With Tislelizumab in Patients With Solid Tumors.
Lay Title: Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
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PROTOCOL: IM043-004 (PI: DR Kenneth O’Byrne) (PART2)
Protocol Title: A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Lay Title: A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
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PROTOCOL: MDNA11-01 (PI: DR Victoria atkinson)
Protocol Title: A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors
Lay Title: Early Phase IL-2 Superkine with and without Immune checkpoint Inhibitor in advanced solid tumour patients.
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PROTOCOL: MK-7902-009 (PI: DR MARGARET MCGRATH)
Short Title: LEAP-009/ Relapsed/Metatstatic Head and Neck Squamous Cell Carcinoma
Protocol Title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy
Lay Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy