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Head and Neck Squamous Cell CarcinomaPhase 1/2ABIMMUNENCT03212469

A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

A Phase 1/2 study testing Durvalumab, Tremelimumab and SBRT in people with Head and Neck Squamous Cell Carcinoma and Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Tremelimumab and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
20 Jun 2017to 24 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • I1. Male or Female patients ≥18 years of age or older.
  • I2. Histologically or cytologically proven metastatic squamous cell carcinoma (from head and neck, oesophagus, lung, cervix, vagina, vulva or anus) with the following features:
  • Previously treated with at least one prior regimen (chemotherapy, signal transduction inhibitors or radiotherapy)
  • To be treated with radiotherapy at primary tumor site or metastatic site or menacing metastatic site.
  • The sites of metastases allowed are: soft tissue, peripheral lung, and liver.
  • Patients with brain and bone metastasis to be treated with radiotherapy are not allowed. Patients with asymptomatic brain metastasis can be included.
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  • The total tumor volume to be irradiated must not exceed 400 cc.
  • I3. At least one tumor lesion must be accessible to radiation therapy and at least another tumor site can be spared from radiation therapy (unirradiated site).
  • I4. At least one unirradiated and one irradiated tumor site must be accessible to tumor biopsy.
  • I5. Known availability of an archived block
  • I6. The irradiated and unirradiated tumor sites must be measurable as per RECIST 1.1
  • I7. Patients must have no history of previous radiation therapy within the body area to be irradiated.
  • I8. Minimal wash-out periods from previous treatments to C1D1 must be
  • Any investigational agent > 4 weeks
  • Bevacizumab > 6 weeks
  • Chemotherapy > 4 weeks
  • TKI > 4 weeks
  • RANK ligand agonists > 6 weeks
  • Immunosuppressive medication > 28 days, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceeding 10 mg/day of prednisone, or an equivalent corticosteroid
  • Live attenuated vaccination > 30 days
  • I9. WHO 0-1, Performance Status ECOG of 0-1
  • I10. Patients must have adequate organ function defined as follows:
  • Absolute neutrophil count of ≥ 1500/mm3,
  • Platelet count≥ 100,000/mm3,
  • Hemoglobin > 9 g/dL,
  • Bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • Serum ALT and AST ≤2.5 ULN (or if liver metastases are present must be ≤ 5x ULN)
  • Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance (see formula in section 4.1).
  • I11. Patients must be free of significant comorbid conditions that would preclude safe administration or completion of protocol therapy.
  • I12. Female patients must either be of non-reproductive potential (ie, postmenopausal ≥ 12 months with no menses without an alternative medical cause OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry (within 72 hours before study drug start).
  • I13. Fertile men with a female partner of childbearing potential must agree to use male condom plus spermicide and childbearing potential women must have agreed to use at least one highly effective contraceptive method during treatment on this trial and for up to 180 days after the last of dose of Durvalumab + Tremelimumab or 90 days after the last dose of Durvalumab monotherapy, whichever is the longer period.
  • I14. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • I15. Patients must be affiliated to a social security system or beneficiary of the same.

Who cannot join

  • E1. Any situation where the irradiation of the target site would imply reirradiation of a formerly irradiated tumor site.
  • E2. Patients with any concurrent severe and/or uncontrolled disease which could compromise participation in the study including:
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
  • Active or prior documented autoimmune disease within the past 2 years. Of note, patient with vitiligo, Grave's disease or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Patients with type 1 diabetes or hypothyroidism stable under treatment or not requiring systemic treatment are eligible.
  • Active or prior documented inflammatory bowel disease (eg Crohn's disease, ulcerative colitis)
  • History of primary immunodeficiency
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  • Severe chronic or acute infection such as chronic HBV, HCV and HIV1, 2 infection, active tuberculosis infection
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active non-infectious pneumonitis
  • History of allogenic organ transplant
  • Uncontrolled diabetes,
  • Prior history of active bleeding diathesis or patients taking an oral vitamin K antagonist (except low-dose Coumadin (warfarin sodium))
  • Symptomatic congestive heart failure,
  • Uncontrolled hypertension,
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Active peptic ulcer disease or gastritis,
  • Any psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the sponsor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.
  • Chronic treatment with corticosteroids or another immunosuppressant
  • E3. Patients with tumors that invade major vessels, as shown unequivocally by imaging studies
  • E4. Patients with central lung metastasis (i.e within 2 cm from hilum) that are cavitary as shown unequivocally by imaging studies
  • E5. Patients with a history of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) ≤ 3 months prior enrolment
  • E6. Major surgery within the last 4 weeks prior to entering the study
  • E7. Persisting significant toxicities related to prior treatments i.e. ≥ Grade 2 AE according to CTCAE V4.03 except alopecia and biological values defined in inclusion criteria I10.
  • E8. Current or planned use of forbidden concomitant medications :
  • Any investigational anticancer therapy not specified in this protocol
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  • Immunosuppressive medications including, but not limited to systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent, methotrexate, azathioprine, and TNF-α blockers. Use of immunosuppressive medications for the management of investigational product-related AEs or in subjects with contrast allergies is acceptable. In addition, use of topical, inhaled and intranasal corticosteroids is permitted.
  • Live attenuated vaccines within 90 days of Durvalumab dosing or within 180 days of Durvalumab and Tremelimumab dosing. Inactivated vaccines, such as the injectable influenza vaccine, are authorized.
  • E9. Any prior Grade ≥ 3 irAE while receiving previous immunotherapy agent or any unresolved irAE > Grade 1.
  • E10. Prior exposure to any anti-PD-1 or anti-PD-L1 or anti-CTLA4 antibody.
  • E11. Known allergy or hypersensitivity to humanized antibodies.
  • E12. Pregnant or breastfeeding women.
  • E13. Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

Official title: A Phase I/II Study Evaluating the Safety and Clinical Activity of Anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) Antibodies Administrated in Combination With Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic Squamous Cell Carcinoma of Head and Neck, Lung, Oesophageus, Cervix, Vagina,Vulva or Anus

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Lung Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses

    Safety run of the triple combination:

    Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses,

    Efficacy step

    • Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
    • SBRT at C1D15, then
    • Durvalumab Q4W alone for up to 9 additional doses

  • TremelimumabDrug

    Preliminary steps : Safety Runs

    Safety run of the triple combination:

    Tremelimumab at 75mg/Q4W for up to 4 doses

    Efficacy step

    • Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
    • SBRT at C1D15, then
    • Durvalumab Q4W alone for up to 9 additional doses

  • SBRTRadiation

    Preliminary steps : Safety Runs

    Safety run of the dual combination:

    SBRT at C1D15.

    Safety run of the triple combination:

    SBRT at C1D15.

    Efficacy step

    • Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
    • SBRT at C1D15, then
    • Durvalumab Q4W alone for up to 9 additional doses
Study groups in NCT03212469
Study groupRoleWhat they receive
Patients with head and neck squamous cell carcinomaExperimentalNot described
Receives: Drug: Durvalumab; Drug: Tremelimumab; Radiation: SBRT
Patients lung cancerExperimentalNot described
Receives: Drug: Durvalumab; Drug: Tremelimumab; Radiation: SBRT
Patients with oesophagus cancerExperimentalNot described
Receives: Drug: Durvalumab; Drug: Tremelimumab; Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT)

    Event possibly related to study drugs and fulfills any one of the following criteria using CTCAE Version 4.03

    Measured: Approximately 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start20 Jun 2017
  3. Primary completion24 Feb 2025
  4. Study completion24 Feb 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study is an open label, multicentric, Phase I/II trial
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212469
Sponsor's protocol ID
2024-514920-18-00
Other IDs
2016/2454
Acronym
ABIMMUNE
Status last verified
May 2025
First submitted
31 Jan 2017
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab, Tremelimumab and SBRT in people with Head and Neck Squamous Cell Carcinoma and Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 33 inclusion and 34 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: finished, as of the sponsor's last update on 8 May 2025. 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 France. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose Limiting Toxicity (DLT) (time frame: Approximately 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03212469.

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 8 May 2025.

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