Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Multi-Arm (Basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination With Pembrolizumab, as First-Line Treatment for Patients With Metastatic NSCLC, SCCHN, or Metastatic mUBC
A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)
Naturally occurring IDO/PD-L1 specific T-cells recognize MHC-bound IDO/PD-L1 peptides, and are able to eliminate IDO expressing or PD-L1 expressing immune regulatory cells and cancer cells. Activation of IDO or PD-L1 specific T-cells through vaccination with the IDO and PD-L1 peptides (IO102-IO103) will boost natural killing of cancer cells and counteract immune regulatory mechanisms in the tumor microenvironment. Thus, IDO/PD-L1 specific T-cells may both directly support anti-cancer immunity by killing target T-cells but also indirectly by releasing pro-inflammatory cytokines in the microenvironment to boost additional anti-cancer immunity. This is a non comparative, open label, unblinded, multi-arm (basket) trial of IO102-IO103 in combination with pembrolizumab in three indications: NSCLC, SCCHN or mUBC. The primary objective of the trial is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab in the frontline treatment in each of the different metastatic solid tumour indications with the intent to expand a specific arm if a clinically meaningful signal is observed based on primary endpoint (dual target of either ORR or PFS by investigator assessment according to RECIST v.1.1). Approximately 90 patients will be enrolled and treated; approximately 30 patients in each arm. All eligible patients will receive treatment for up to 2 years with IO102-IO103 (IO102 85μg and IO103 185μg) SC Q3W in combination with pembrolizumab IV 200mg Q3W. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03317327 -
REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02892201 -
Pembrolizumab in HNSCC With Residual Disease After Radiation
|
Phase 2 | |
| Active, not recruiting |
NCT04854499 -
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT04110249 -
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
|
N/A | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05338905 -
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
|
N/A | |
| Recruiting |
NCT04045496 -
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04096638 -
Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03070366 -
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
|
Phase 2 | |
| Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
| Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
| Terminated |
NCT02488629 -
Study of SCB01A in Patient With Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01697800 -
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
|
Phase 2 | |
| Completed |
NCT01427478 -
Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck
|
Phase 3 | |
| Recruiting |
NCT05437380 -
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
|
N/A | |
| Recruiting |
NCT05065086 -
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
|
||
| Completed |
NCT03022409 -
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
|
Phase 1 |