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Oropharyngeal Squamous Cell CarcinomaPhase 2NCT03410615

Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC

A Phase 2 study testing Radiation, Cisplatin and Durvalumab in people with Oropharyngeal Squamous Cell Carcinoma, run by Canadian Cancer Trials Group at 26 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Squamous Cell Carcinoma
What is being tested?
Radiation, Cisplatin and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
26 sitesin 4 countries
Study dates
28 May 2018to 31 Jul 2026
Phase
Phase 2
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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

Canada14 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Belgium6 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital of Antwerp

    Edegem

  • University Hospital of Gent

    Ghent, 9000

  • University Hospital Leuven

    Leuven, B-3000

  • Clinique St. Elizabeth

    Namur, 5000

  • AZ Sint Augustinus

    Wilrijk, B-2610

Other trials in Belgium

Spain5 sites

  • University Hospital Vall dHebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    Barcelona, 08907

  • University Hospital Ramon y Cajal

    Madrid, 28034

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • University Clinical Hospital of Valencia

    Valencia, 46010

Other trials in Spain

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

About this study

Official title: Randomized Phase II Study of Cisplatin Plus Radiotherapy Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Durvalumab Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)

Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards

Read the detailed description

This study is looking at whether a type of drug called durvalumab can be used with radiation during the initial treatment, (instead of cisplatin) and also afterwards as additional therapy. Durvalumab is an immunotherapy drug . It has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect the cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals. It has been studied in more than 5000 people, approved for use in other cancers and seems promising.

This clinical trial will also test another type of immunotherapy drug called tremelimumab, which would also be given as additional treatment. Tremelimumab works in a different way to durvalumab to enhance the immune system reaction against cancer cells and may improve the effect of durvalumab. Tremelimumab may also help slow the growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink tumours in animals. Tremelimumab has been studied in over 1200 people, approved for use in other cancers and seems promising.

As of February 2019, tremelimumab will no longer be tested with new participants joining the study.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • RadiationRadiation

    70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction)

  • CisplatinDrug

    100 mg/m2 days 1, 22, 43 concurrently with RT

  • DurvalumabDrug

    Given in concurrent and adjuvant phase

  • TremelimumabDrug

    ARM CLOSED TO ACCRUAL - 2019

Study groups in NCT03410615
Study groupRoleWhat they receive
Radiation/CisplatinActive comparatorAll patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Cisplatin IV 100 mg/m2 days 1, 22, 43 concurrently with RT
Receives: Radiation: Radiation; Drug: Cisplatin
Radiation/Durvalumab + Adjuvant DurvalumabExperimentalAll patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Concurrent Phase: Durvalumab IV 1500 mg, days -7 and 22 (the second dose is given concurrently with RT). Adjuvant Phase (to start 4 weeks after completion of concurrent phase): Durvalumab IV 1500 mg q4 weekly for 6 doses.
Receives: Radiation: Radiation; Drug: Durvalumab
Radiation/Durvalumab + Adjuvant Durvalumab/TremelimumabExperimentalARM CLOSED TO ACCRUAL WITH AMENDMENT #1
Receives: Radiation: Radiation; Drug: Durvalumab; Drug: Tremelimumab

What is being measured

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

  1. 3 year event-free survival

    Event-free survival (EFS), is defined as the time from randomization to the time when a failure event is observed. Failure is define by Local-regional progression or recurrence, Distant metastasis, Non-protocol RT, chemotherapy, Surgery or death.

    Measured: 3 years

Secondary outcomes (13)

  1. Functional Assessment of Cancer Therapy-Head and Neck Version (FACT-HN) score.

    The FACT-H\&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients (1-3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms.

    Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as an global QoL score. Higher scores represent better QoL.

    Measured: 6 years

  2. Local regional failure

    Locoregional control defined as time from randomization to the time of first documented local (primary site) or regional (lymph node) recurrence

    Measured: 6 years

  3. Distant metastasis-free survival

    Distant metastasis-free survival defined as time from randomization to the time of first documented distant metastasis or death from any cause

    Measured: 6 years

  4. Overall survival

    Overall Survival defined as time from randomization to the time of death from any cause

    Measured: 6 years

  5. Cost-effectiveness of immunotherapy-based treatment arm vs standard of RT and cisplatin in patients with intermediate risk LA-OSC using the EQ-5D-5L

    Measured: 6 years

  6. Number and severity of adverse events

    Measured: 6 years

  7. Cost-utility will be used to abstract indirect costs at the end of RT and at 6 and 12 months post RT

    Measured: 6 & 12 months

  8. Lost productivity questionnaire will be used to abstract indirect costs at the end of RT and at 6 and 12 months post RT

    Measured: 6 & 12 months

  9. Incidence of second cancer

    Measured: 6 years

  10. PRO-CTCAE baseline, last week of treatment, 3 months, 6 months and 12, 24 and 36 months from the end of RT

    Measured: 3, 6, 12, 24 and 36 months

  11. Dysphagia: PSS-HN swallowing subscale at 36 months from the end of RT

    Measured: 36 months

  12. Dysphagia: using MDADI Global at 36 months from the end of RT

    Measured: 36 months

  13. Number and severity of radiation-related late toxicity at 3 months, 6 months and 1 year from the end of RT

    Measured: 3 months, 6 months & 1 year

Timeline

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

  1. First posted25 Jan 2018
  2. Study start28 May 2018
  3. Primary completion9 Jan 2026
  4. Study completion31 Jul 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a non-comparative, randomized, phase II study of cisplatin plus radiotherapy or durvalumab plus radiotherapy followed by adjuvant durvalumab or durvalumab plus radiotherapy followed by adjuvant tremelimumab and durvalumab in intermediate risk, HPV-positive, locoregionally advanced oropharyngeal squamous cell cancer (LA-OSCC) of the head and neck.
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410615
Sponsor's protocol ID
HN9
Status last verified
Mar 2026
First submitted
9 Jan 2018
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation, Cisplatin and Durvalumab in people with Oropharyngeal Squamous Cell Carcinoma, run by Canadian Cancer Trials Group at 26 sites in 4 countries.

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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Canada, Belgium, Spain, Italy. 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 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?

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?

3 year event-free survival (time frame: 3 years). 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 NCT03410615.

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 24 Mar 2026.

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