Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

NCT04470024 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2020000480
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

Conditions

Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Adverse Events Assessment

  frequency, duration, and severity of adverse events

  from time of informed consent through 90 days after the last study treatment

Secondary Outcomes (3)

• ORR, DOR, DCR

  week 12, 24, and every 12 weeks thereafter

• Overall survival (OS)

  1 year, 2 years, and study completion

• Duration of disease control

  week 12, 24, and every 12 weeks thereafter

Study Arms (2)

Arm 1

EXPERIMENTAL

Vax + delayed anti-PD-1

Drug: INCMGA00012; Biological: DPV-001

Arm 2 (CLOSED TO ENROLLMENT)

EXPERIMENTAL

Vax + anti-GITR + delayed anti-PD-1

Drug: INCAGN01876; Drug: INCMGA00012; Biological: DPV-001

Interventions

INCAGN01876 DRUG

agonistic antihuman GITR mAb

Arm 2 (CLOSED TO ENROLLMENT)

INCMGA00012 DRUG

humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1

Arm 1; Arm 2 (CLOSED TO ENROLLMENT)

DPV-001 BIOLOGICAL

autophagosome cancer vaccine

Arm 1; Arm 2 (CLOSED TO ENROLLMENT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C)
• Age 18 years or above.
• Laboratory values:
• WBC ≥2000/uL
• Hgb \>8.0 g/dl (patients may be transfused to reach this level)
• Platelets \>75,000 cells/mm3
• Serum creatinine clearance ≥ 50 mL/min measured or calculated by Cockcroft-Gault (C-G) equation
• Negative bHCG (urine/serum) Women of childbearing potential only
• AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of laboratory normal (ULN) OR ≤ 5 × ULN for participants with liver metastases
• Alkaline phosphatase ≤2.5 × ULN OR ≤ 5 × ULN for participants with liver metastases
• Total bilirubin ≤1.5 × ULN. If total bilirubin is \>1.5, conjugated bilirubin must be ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then conjugated bilirubin must be \< 40% of total bilirubin.
• Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non-detectable by qPCR.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is non-detectable by qPCR.
• Patients positive for HIV 1/2 antibodies, are eligible if ARV treatment compliant with documented stable CD4 \> 300 for at least 6 months and undetectable viral load

You may not qualify if:

• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
• Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
• Radiation therapy in the thoracic region that is \> 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of organ transplant, including allogeneic stem cell transplantation.
• Uncontrolled intercurrent illness as deemed by the investigator, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease or history of, serious chronic gastrointestinal conditions associated with diarrhea, active noninfectious pneumonitis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• History of another primary malignancy except for:
• Malignancy treated with curative intent and with no known active disease ≥1.5 years before the first dose of investigational product and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• History of leptomeningeal carcinomatosis
• Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients whose brain metastases have been treated may participate provided they show radiographic stability (imaging at least four weeks apart showing no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg/day of prednisone or its equivalent and anti-seizure medications for at least 14 days prior to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy unrelated to cancer are eligible for the trial.

Sponsors & Collaborators

• Providence Health & Services: lead

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

George Morris

CONTACT

503-215-7503; george.morris@providence.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will have a run-in safety phase for each of the 2 arms, starting with arm 1 using a standard 3+3 design. If arm 1 is deemed safe, the safety run-in for arm 2 will begin enrollment, using the same 3+3 design. If arm 2 is deemed safe, enrollment will continue to 15 in each arm (total n = 30). Patients enrolling after the safety run-in will be randomly assigned to either arm 1 or arm 2.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: August 5, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)