HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT04369937|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|HPV-Related Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma||Radiation: IMRT (Intensity Modulated Radiotherapy) Drug: Pembrolizumab Drug: Cisplatin Biological: ISA101b||Phase 2|
This study aims to enroll 50 patients (male and female, age 18+) who have intermediate risk disease with histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. All patients will receive the same treatment and there is no active control group.
In this trial, patients will undergo biopsy followed by treatment with ISA101b vaccine which will be initiated 2 weeks prior to cisplatin-IMRT, and one week prior to the first dose of pembrolizumab. Vaccines will continue for 2 additional administrations at weeks 2 and 5, on the same day as successive pembrolizumab infusions. Pembrolizumab will be initiated 1 week prior to cisplatin-IMRT at the dose of 200 mg IV q3 weeks (+/- 3 days). Pembrolizumab will be continued concurrently through cisplatin-IMRT (weeks 3, 6 ), and continued for a 15 week maintenance period after completion of cisplatin-IMRT for a total pembrolizumab treatment period of 24 weeks (8 doses; 6 months).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating HPV-16 Vaccination (ISA101b) and Pembrolizumab Plus Cisplatin Chemoradiotherapy for "Intermediate Risk" HPV-16 Associated Head and Neck Squamous Cell Carcinoma (HNSCC)|
|Actual Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: IMRT + Pembrolizumab + Cisplatin + ISA101b
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
Radiation: IMRT (Intensity Modulated Radiotherapy)
A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
Other Name: HPV-16 Vaccine
- Progression-free Survival (PFS) at 2 years [ Time Frame: Up to 2 years ]The proportion of participants whose disease has to progressed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 2 years. PFS will be calculated from treatment initiation to disease progression or death from any cause for 2 years. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Adverse Events Related to Study Treatment [ Time Frame: Up to 3 years ]The percentage of Serious Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 that are possibly, probably or definitely related to study treatment.
- Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]The length of time during and after the treatment that patients remain alive with disease that does not progress. PFS will be calculated from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Overall Survival (OS) [ Time Frame: Up to 3 years ]The length of time (months) from the initiation of treatment that patients are still alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369937
|Contact: Jennifer Ruth, RN, BSNfirstname.lastname@example.org|
|Contact: Rosemarie Angelo, RN, BSNemail@example.com|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Jennifer Ruth, RN, BSN 412-623-8963 firstname.lastname@example.org|
|Contact: Rosemarie Angelo, RN, BSN 412-623-7039 email@example.com|
|Principal Investigator: Robert L Ferris|
|Principal Investigator:||Robert L Ferris, MD, PhD||UPMC Hillman Cancer Center|