Cancer of the Head and NeckPhase 1NCT04470024
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC
A Phase 1 study testing INCAGN01876, INCMGA00012 and DPV-001 in people with Cancer of the Head and Neck, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- INCAGN01876, INCMGA00012 and DPV-001
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
- Ability to give informed consent and comply with the protocol.
- Anticipated lifespan greater than 12 weeks.
- Women of childbearing potential must have negative serum/urine pregnancy test <5 days prior to start of study.
- Males and women of childbearing potential, must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of study treatment (see Appendix A).
Who cannot join
- 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.
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- 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.
- History of active primary immunodeficiency.
- Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent).:
- Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
- Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
- Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
- Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedication are permitted.
- Receipt of live attenuated vaccine within 28 days prior to the first dose of study treatment. Note: patients should not receive live vaccine during study treatment and up to 30 days after the last dose of study treatment.
- Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
- Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Principal Investigator or one of the Co-Principal Investigators.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by study treatment may be included only after consultation with the Principal Investigator or one of the Co-Principal Investigators.
- Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines) OR
- any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
- Receipt of systemic antibiotics ≤ 7 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Portland Providence Medical Center
Portland, Oregon, 97213
About this study
Official title: A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
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.
Read the detailed description
This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT at 12 weeks. Subsequent restaging CT will be performed at week 24 and every 12 weeks thereafter. Starting at week 22, dosing of DPV-101 will switch to a q4wk schedule, while the schedule of anti-GITR and anti-PD1 will remain unchanged.
- Conditions
- Cancer of the Head and Neck
- Being tested
- INCAGN01876, INCMGA00012, DPV-001
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN01876Drug
agonistic antihuman GITR mAb
INCMGA00012Drug
humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
DPV-001Biological
autophagosome cancer vaccine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Vax + delayed anti-PD-1 Receives: Drug: INCMGA00012; Biological: DPV-001 |
| Arm 2 (CLOSED TO ENROLLMENT) | Experimental | Vax + anti-GITR + delayed anti-PD-1 Receives: Drug: INCAGN01876; Drug: INCMGA00012; Biological: DPV-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Assessment
frequency, duration, and severity of adverse events
Measured: from time of informed consent through 90 days after the last study treatment
Secondary outcomes (3)
ORR, DOR, DCR
Determined by investigator assessment per RECIST v1.1
Measured: week 12, 24, and every 12 weeks thereafter
Overall survival (OS)
Determined from the start of combination until death due to any cause
Measured: 1 year, 2 years, and study completion
Duration of disease control
Measured from first report of SD or better (per RECIST v1.1) until PD or death
Measured: week 12, 24, and every 12 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start5 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470024
- Sponsor's protocol ID
- 2020000480
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT04470024
- Acronym / sponsor ID
- 2020000480
- Conditions
- Cancer of the Head and Neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT at 12 weeks. Subsequent restaging CT will be performed at week 24 and every 12 weeks thereafter. Starting at week 22, dosing of DPV-101 will switch to a q4wk schedule, while the schedule of anti-GITR and anti-PD1 will remain unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: INCMGA00012, Biological: DPV-001Vax + delayed anti-PD-1 |
| Arm 2 (CLOSED TO ENROLLMENT) | Experimental | Drug: INCAGN01876, Drug: INCMGA00012, Biological: DPV-001Vax + anti-GITR + delayed anti-PD-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCAGN01876agonistic antihuman GITR mAb | Drug | Arm 2 (CLOSED TO ENROLLMENT) |
| INCMGA00012humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1 | Drug | Arm 1, Arm 2 (CLOSED TO ENROLLMENT) |
| DPV-001autophagosome cancer vaccine | Biological | Arm 1, Arm 2 (CLOSED TO ENROLLMENT) |
Primary outcome
Adverse Events Assessment
Time frame: from time of informed consent through 90 days after the last study treatment
frequency, duration, and severity of adverse events
3 secondary outcomes
ORR, DOR, DCR
Time frame: week 12, 24, and every 12 weeks thereafter
Overall survival (OS)
Time frame: 1 year, 2 years, and study completion
Duration of disease control
Time frame: week 12, 24, and every 12 weeks thereafter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCAGN01876, INCMGA00012 and DPV-001 in people with Cancer of the Head and Neck, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Assessment (time frame: from time of informed consent through 90 days after the last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.