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Immunotherapy may replace chemo for some throat cancers

NCT ID NCT03410615

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial compares standard treatment (radiation plus chemotherapy drug cisplatin) against two experimental arms using the immunotherapy drug durvalumab with radiation, followed by either durvalumab alone or durvalumab plus another immunotherapy, tremelimumab. The study includes 129 patients with HPV-positive, intermediate-risk oropharyngeal cancer. The goal is to see if immunotherapy can control the cancer as well as chemotherapy, with potentially fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Durvalumab (an immunotherapy drug) and Tremelimumab (another immunotherapy drug), compared to Cisplatin (chemotherapy)
What this could lead to
If successful, this could offer a less toxic alternative to chemotherapy for HPV-positive throat cancer patients, potentially reducing side effects while keeping the cancer from returning.
What could go wrong
This is a phase 2 trial with only 129 participants, so results are preliminary. Immunotherapies can cause serious immune-related side effects, and the tremelimumab arm was closed early due to recruitment issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

129 people

The number who actually took part.

Started

May 2018

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx (OSCC) which is locoregionally advanced, intermediate risk and non-metastatic (M0) as defined by the following (UICC/AJCC 8th Edition staging) * T1-2 N1 (smoking ≥ 10 pack years); * T3 N0-N1 (smoking ≥ 10 pack years); * T1-3 N2 (any smoking hx). * Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumour specimens. Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70% or more of the tumour cells. Local testing is acceptable; testing will not be done centrally in real-time. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix I) and a body weight of \> 30 kg. * The following radiological investigations must be done within 8 weeks of randomization: * CT or MRI of the neck (with PET-CT and head imaging as indicated); * CT chest or x-ray, other radiology tests as clinically indicated. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. * Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin fixed paraffin block, of non-cytology tissue samples in order that the specific correlative mark assays may be conducted. * Patient must consent to provision of samples of blood, saliva and oropharyngeal swab in order that the specific correlative marker assays may be conducted * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in the languages provided. * Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre * In accordance with CCTG policy, protocol treatment (cisplatin/RT or durvalumab) is to begin within 1 week of randomization. * The patient is not receiving anti-cancer therapy in a concurrent clinical study testing new treatments or treatment strategies and the patient agrees not to participate in other clinical studies during their participation in this trial while on study treatment. * Adequate normal organ and marrow function as defined below (must be done within 14 days prior to randomization): Absolute neutrophils - ≥ 1.5 x 10\^9/L; Platelets ≥100 x 10\^9; Hemoglobin ≥90 g/L; Bilirubin ≤ 1.5 x UNL; AST and ALT ≤2.5 x UNL; Creatine clearance ≥ 60 mL/min. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements * Patients must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation including administration of radiotherapy, cisplatin and durvalumab as outlined in the protocol. Exclusion Criteria: * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. * Current history of other non-OSCC malignancies of the head and neck. * Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab. * Any previous cisplatin or carboplatin chemotherapy. * Any previous induction chemotherapy for current SCCHN. * Any previous surgical treatment of the current cancer (except for a diagnostic biopsy) and no major surgery within 28 days prior to randomization. * Any previous radiation to the head and neck region that would result in overlap of fields for the current study. * History of allergic or hypersensitivity reactions to any study drug or their excipients. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome. * History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization\* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction * Current or prior use of immunosuppressive medication within 28 days of study entry, with the exceptions of intranasal and inhaled corticosteroids or systemic chronic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Corticosteroids used on study for anti-emetic purpose are allowed. Corticosteroids as premedication for hypersensitivity reactions (e.g. computed tomography \[CT\] scan premedication) are allowed. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease (controlled by diet alone) or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: * Patients with vitiligo or alopecia; * Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years); * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement; * Any chronic skin condition that does not require systemic therapy. * Patients with active or uncontrolled intercurrent illness including, but not limited to: * cardiac dysfunction (symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia); * active peptic ulcer disease or gastritis; * active bleeding diatheses; * psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent; * known history of previous clinical diagnosis of tuberculosis; * known active human immunodeficiency virus infection (positive HIV 1/2 antibodies); HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible; * known active hepatitis B infection (positive HBV surface antigen (HBsAg). Patients with a past or resolved HBV infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible; * known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline CT scan. * Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to randomization. * Pregnant or lactating women * Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy. * Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol

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Conditions

The condition(s) this trial relates to.

oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AZ Sint Augustinus

    Wilrijk, B-2610, Belgium

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Clinique St. Elizabeth

    Namur, 5000, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Hospital Duran i Reynals

    Barcelona, 08907, Spain

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1, Canada

  • University Clinical Hospital of Valencia

    Valencia, 46010, Spain

  • University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Leuven

    Leuven, B-3000, Belgium

  • University Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • University Hospital Vall dHebron

    Barcelona, 08035, Spain

  • University Hospital of Antwerp

    Edegem, Belgium

  • University Hospital of Gent

    Ghent, 9000, Belgium

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