Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513884
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Phase 23 Study of HB-202HB-201 With Pembrolizumab in Patients With HPV16 RecurrentMetastatic Oropharyngeal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blinded Phase 23 Study of HB-202HB-201 Alternating 2-Vector Therapy With Pembrolizumab Versus Pembrolizumab-Only for First Line HPV16 High PD-L1 CPS Recurrent andor Metastatic Oropharyngeal Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of HB-202HB-201 alternating 2-vector therapy with pembrolizumab also known as Keytruda in people with human papillomavirus subtype 16 positive HPV16 head and neck cancer starting in the middle part of the throat who have not yet received systemic treatment after their cancer spread metastatic andor returned recurrent and who are eligible to receive pembrolizumab
Doctors already use pembrolizumab therapy with or without chemotherapy to treat head and neck cancer However the treatment does not work well in most people with this type of cancer HB-202HB-201 alternating 2-vector therapy with pembrolizumab which is designated to stimulate a stronger immune attack against HPV16 tumors was shown to be safe and suggested to work better than pembrolizumab-only in a small number of participants with HPV16 head and neck cancer see H-200-001 NCT04180215
This trial studies HB-202HB-201 alternating 2-vector therapy with pembrolizumab in a much larger number of participants from different countries to confirm its benefits for people with HPV16 head and neck cancer that started in the middle part of the throat compared with pembrolizumab-only therapy This trial studies whether administering HB-202HB-201 alternating 2-vector therapy with pembrolizumab works better in more participants by shrinking their tumors and makes them live longer than pembrolizumab-only therapy
Participants will receive the study treatments by injection into a vein every 3 weeks during the first 3 months and then every 6 weeks until up to about 2 years which will be followed by a long observation period to continue looking at the safety and clinical benefits after the last dose of study treatment
Doctors already use pembrolizumab therapy with or without chemotherapy to treat head and neck cancer However the treatment does not work well in most people with this type of cancer HB-202HB-201 alternating 2-vector therapy with pembrolizumab which is designated to stimulate a stronger immune attack against HPV16 tumors was shown to be safe and suggested to work better than pembrolizumab-only in a small number of participants with HPV16 head and neck cancer see H-200-001 NCT04180215
This trial studies HB-202HB-201 alternating 2-vector therapy with pembrolizumab in a much larger number of participants from different countries to confirm its benefits for people with HPV16 head and neck cancer that started in the middle part of the throat compared with pembrolizumab-only therapy This trial studies whether administering HB-202HB-201 alternating 2-vector therapy with pembrolizumab works better in more participants by shrinking their tumors and makes them live longer than pembrolizumab-only therapy
Participants will receive the study treatments by injection into a vein every 3 weeks during the first 3 months and then every 6 weeks until up to about 2 years which will be followed by a long observation period to continue looking at the safety and clinical benefits after the last dose of study treatment
Detailed Description:
This is a seamless adaptive Phase 23 randomized double-blinded placebo-controlled multicenter trial of HB-202HB-201 alternating 2-vector therapy with the approved drug pembrolizumab in participants with HPV16 recurrent andor metastatic oropharyngeal squamous cell carcinoma OPSCC whose tumor has a programmed cell death ligand-1 PD-L1 combined positive score CPS greater than or equal to 20 in the first line setting OPSCC is a type of head and neck squamous cell carcinoma HNSCC originating in the oropharyngeal region tonsil tongue base soft palate or uvula The study will evaluate the long-term safety and the benefits on objective response rate overall survival and progression-free survival of HB-202HB-201 alternating 2-vector therapy plus pembrolizumab compared with pembrolizumab-only therapy
Pembrolizumab-only therapy or pembrolizumab plus chemotherapy are currently the first-line therapies used to treat people with recurrent andor metastatic HNSCC including HPV OPSCC However poor prognosis prevails despite pembrolizumab therapy with or without chemotherapy including patients with PD-L1 CPS greater or equal to 20 where only a minority of patients respond
HB-202 and HB-201 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus respectively The HB-202 and HB-201 vectors have been engineered to deliver specific non-oncogenic antigens derived from HPV16 which enables the vectors to stimulate a strong and specific immune response against HPV16 tumor cells Pembrolizumab on the other hand is a potent checkpoint inhibitor which binds to immune cell surface receptors to relieve the typical inhibition of immune surveillance of tumors In an early phase trial H-200-001 NCT04180215 HB-202HB-201 alternating 2-vector therapy with pembrolizumab has shown favorable safety and preliminary anti-tumor activity with an objective response rate higher than previously reported with pembrolizumab-only therapy in participants with HPV16 OPSCC
HB-202HB-201 alternating 2-vector therapy or matched placebo will be administered in treatment cycles A treatment cycle is defined as one administration of HB-202 plus the post-dose period followed by one administration of HB-201 plus the post-dose period until the next dose In the first 2 treatment cycles the HB-202HB-201 or matched placebo treatment is administered with 200 mg pembrolizumab every 3 weeks The HB-202HB-201 or matched placebo treatment is administered with 400 mg pembrolizumab every 6 weeks from the third treatment cycle onwards Adverse events AEs will be monitored for up to 30 days and serious AEs for up to 90 days after the last dose of study treatment There will be long-term follow-up every 3 months after the last administration of study treatment for all participants until the participants death the participant is lost to follow-up or withdraws consent to follow-up last study-related phone call or visit or study termination whichever occurs first
Participants will be randomized to receive either HB-202HB-201 alternating 2-vector therapy followed by pembrolizumab or matched placebo ie matched to the respective viral vector followed by pembrolizumab
Up to 150 Investigators and study sites in North America Europe and other regions of the world are expected to enroll participants in this study
Pembrolizumab-only therapy or pembrolizumab plus chemotherapy are currently the first-line therapies used to treat people with recurrent andor metastatic HNSCC including HPV OPSCC However poor prognosis prevails despite pembrolizumab therapy with or without chemotherapy including patients with PD-L1 CPS greater or equal to 20 where only a minority of patients respond
HB-202 and HB-201 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus respectively The HB-202 and HB-201 vectors have been engineered to deliver specific non-oncogenic antigens derived from HPV16 which enables the vectors to stimulate a strong and specific immune response against HPV16 tumor cells Pembrolizumab on the other hand is a potent checkpoint inhibitor which binds to immune cell surface receptors to relieve the typical inhibition of immune surveillance of tumors In an early phase trial H-200-001 NCT04180215 HB-202HB-201 alternating 2-vector therapy with pembrolizumab has shown favorable safety and preliminary anti-tumor activity with an objective response rate higher than previously reported with pembrolizumab-only therapy in participants with HPV16 OPSCC
HB-202HB-201 alternating 2-vector therapy or matched placebo will be administered in treatment cycles A treatment cycle is defined as one administration of HB-202 plus the post-dose period followed by one administration of HB-201 plus the post-dose period until the next dose In the first 2 treatment cycles the HB-202HB-201 or matched placebo treatment is administered with 200 mg pembrolizumab every 3 weeks The HB-202HB-201 or matched placebo treatment is administered with 400 mg pembrolizumab every 6 weeks from the third treatment cycle onwards Adverse events AEs will be monitored for up to 30 days and serious AEs for up to 90 days after the last dose of study treatment There will be long-term follow-up every 3 months after the last administration of study treatment for all participants until the participants death the participant is lost to follow-up or withdraws consent to follow-up last study-related phone call or visit or study termination whichever occurs first
Participants will be randomized to receive either HB-202HB-201 alternating 2-vector therapy followed by pembrolizumab or matched placebo ie matched to the respective viral vector followed by pembrolizumab
Up to 150 Investigators and study sites in North America Europe and other regions of the world are expected to enroll participants in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None