A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03821272|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: PepCan Biological: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status|
|Actual Study Start Date :||November 13, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
Placebo Comparator: Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
0.9% Saline solution per dose administered intradermally in the extremities
- Adverse events - evaluate safety of a 7-injection regimen of PepCan. [ Time Frame: 2 years ]To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.
- Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan [ Time Frame: 2 years ]To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.
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): NCT03821272
|Contact: Aaron J Holleyemail@example.com|
|Contact: Omar Atiq, MD||501-526-6990 ext 8176||OTAtiq@uams.edu|
|United States, Arkansas|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Aaron J Holley, BA, CCRP 501-686-8274 JAHolley@uams.edu|
|Principal Investigator: Omar Atiq, MD|
|Sub-Investigator: Mayumi Nakagawa, MD, PhD|
|Principal Investigator:||Omar T Atiq, MD||University of Arkansas|