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Trial Title:
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)
NCT ID:
NCT05787639
Condition:
Oropharynx Cancer
Conditions: Official terms:
Papilloma
Oropharyngeal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A phase II clinical trial for AJCC (American Joint Committee on Cancer) VIII Stage I
T1-2N1M0 HPVOPC, including patients amenable to surgical resection, excluding patients
with solitary lymph nodes less than 3 cm who are amenable to surgical therapy alone.
Stereotactic radiation therapy (SBRT (8GyX3)) will be delivered to gross tumor volume
(GTV) +3mm, followed by Pembrolizumab 200 mg IV and Evorpacept 45 mg/kg IV every three
weeks x 2 cycles followed by surgical resection of primary tumor and neck dissection. The
primary endpoint is pathologic response compared to historical standard of care rates of
locoregional control, and secondary endpoints are clinical response, survival, and safety
and toxicity.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Evorpacept
Description:
After stereotactic radiation to primary tumor and neck on week 1 of study, Evorpacept 45
mg/kg is administered by IV infusion every three weeks starting on Week 2, Day 1 of study
for a total two 21-day cycles (6 weeks)
Arm group label:
Treatment
Other name:
ALX 148
Summary:
The majority of head and neck cancer patients do not respond to immunotherapies, and
clinical responses are often not durable. However, targeting tumors with stereotactic
radiation in combination with immunotherapy while sparing draining lymphatics enhances
anticancer immunity, resulting in dramatic response in HPV (Human Papilloma Virus) virus
related cancers of the throat. This trial will leverage targeted tumor radiation and
immunotherapy in advance of standard surgical therapy to improve the response of HPV
(Human Papilloma Virus) throat cancer to radiation and immunotherapy.
Detailed description:
This is a prospective, multi-center, open-label, one-arm, two-stage, Phase II study to
evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) in patients with stage I
HPVOPC (Human Papilloma Virus Oropharynx Cancer) amenable to surgical resection,
including AJCC (American Joint Committee on Cancer) VIII T1-2N1M0 HPVOPC (Human Papilloma
Virus Oropharynx Cancer) and excluding patients with solitary lymph nodes less than 3 cm.
A Simon's two-stage optimal design is used for this study. We will test the hypothesis
that neoadjuvant stereotactic tumor targeting radiation along with CD47 inhibition
(evorpacept) and PD-1 inhibition (pembrolizumab) provides pathologic response compared to
current standard of care rates of locoregional control.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of Stage I T1-2N1M0 HPVOPC (Human Papilloma Virus
Oropharynx Cancer)
- Amenable to surgical resection
- Are able to safely receive neoadjuvant radiation and Evorpacept/Pembrolizumab
Exclusion Criteria:
• Patients with solitary lymph nodes less than 3 cm
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Start date:
February 20, 2024
Completion date:
May 30, 2028
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787639
https://pubmed.ncbi.nlm.nih.gov/33963014/
