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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05459129




Registration number
NCT05459129
Ethics application status
Date submitted
12/07/2022
Date registered
14/07/2022

Titles & IDs
Public title
A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)
Scientific title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)
Secondary ID [1] 0 0
CO43613
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Active comparator: Atezo + Tira - Participants in the atezolizumab plus tiragolumab arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.

Experimental: Atezo + Tira + CP - Participants in the atezolizumab plus tiragolumab plus carboplatin plus paclitaxel arm arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Treatment: Drugs: Tiragolumab
Tiragolumab will be administered intravenously at a fixed dose of 600 mg on Day 1 of each 21-day cycle.

Treatment: Drugs: Carboplatin
Carboplatin will be administered intravenously at a dose of area under the concentration-time curve (AUC) 5 mg/mL/min on Day 1 of each 21 day cycle.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered intravenously at a dose of 175 mg/m2 on Day 1 of each 21 day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathologic Complete Response (pCR), as Determined by Local Pathologic Review
Timepoint [1] 0 0
At the time of surgery
Secondary outcome [1] 0 0
Pathologic Response Rate (pRR), as Determined by Local Pathologic Review
Timepoint [1] 0 0
At the time of surgery
Secondary outcome [2] 0 0
Event-Free Survival (EFS)
Timepoint [2] 0 0
Randomization up to approximately 5 years
Secondary outcome [3] 0 0
Relapse-Free Survival (RFS)
Timepoint [3] 0 0
Surgery up to approximately 5 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Randomization up to approximately 5 years
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
After completion of neoadjuvant treatment
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events
Timepoint [6] 0 0
Up to 5 years after first participant enrolled
Secondary outcome [7] 0 0
Percentage of Participants with Immune-Related Adverse Events Grade >=3
Timepoint [7] 0 0
Up to Week 12 after first participant enrolled
Secondary outcome [8] 0 0
Rate of Delayed Surgery Due to Treatment-Related Adverse Events
Timepoint [8] 0 0
>=2 weeks delay from the planned surgery
Secondary outcome [9] 0 0
Duration of Delayed Surgery Due to Treatment-Related Adverse Events
Timepoint [9] 0 0
>=2 weeks delay from the planned surgery
Secondary outcome [10] 0 0
Surgical Complication Rates
Timepoint [10] 0 0
From surgery through follow-up (up to approximately 5 years)
Secondary outcome [11] 0 0
Landmark EFS
Timepoint [11] 0 0
Randomization to specified timepoints (1, 2, 3, and 5 years)
Secondary outcome [12] 0 0
Landmark RFS
Timepoint [12] 0 0
From surgery to specified timepoints (1, 2, 3, and 5 years)
Secondary outcome [13] 0 0
Landmark OS
Timepoint [13] 0 0
Randomization to specified timepoints (1, 2, 3, and 5 years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Histologically confirmed, resectable Stage III-IVA SCCHN
* Eligible candidate for R0 resection with curative intent at the time of screening
* HPV-negative test for oropharyngeal carcinoma, as determined locally by p16 immunohistochemistry (IHC), in situ hybridization, or polymerase chain reaction-based assay
* Measurable disease (at least one target lesion), as assessed according to RECIST v1.1
* PD-L1 expression, defined as a combined positive score (CPS) >= 1
* Adequate hematologic and end-organ function
* Negative HIV test with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load.
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), Positive total hepatitis B core antibody (HBcAb) followed by a negative quantitative hepatitis B virus (HBV) DNA.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* HPV-positive oropharyngeal cancer, as determined locally by p16 IHC, in situ hybridization, or by polymerase chain reactions-based assay
* Distantly metastasized SCCHN
* Any prior therapy for SCCHN, including immunotherapy, chemotherapy, or RT
* Prior treatment with any of the protocol-specified study treatments
* Treatment with investigational therapy within 42 days prior to initiation of study treatment
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT scan)
* History of malignancy other than SCCHN within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5 -year OS rate>90%)
* Active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
* Treatment with therapeutic or prophylactic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment
* Significant cardiovascular disease such a New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhytmia, or unstable angina
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to study initiation of study treatment, or anticipation of need for a major surgical procedure other than tumor resection, during the study
* Any of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of investigational drug, may affect the interpretation of the results, impair the ability of the patient to participate in the study, or renders the patient at high risk form treatment complications
* History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies
* Known allergy or hypersensitivity to any of the study drugs or their excipients
* Known intolerance to any of the drugs required for premedication
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Eligible only for the control arm
* Active EBV infection or known or suspected chronic EBV infection at screening

Specific Exclusion Criteria for Atezo+Tira+CP:

* Known severe allergy or hypersensitivity to placlitaxel, platinum or platinum-containing compounds
* Known history of severe hypersensitivity to products containing Cremophor EL
* Creatinine clearance <45m./min (Calculated using the Cockcroft-Gault formula)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2024
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital; Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
France
State/province [6] 0 0
Caen
Country [7] 0 0
France
State/province [7] 0 0
CHU Hopitaux De Bordeaux
Country [8] 0 0
France
State/province [8] 0 0
Lyon
Country [9] 0 0
France
State/province [9] 0 0
Vandoeuvre-Les-Nancy
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CO43613 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05459129