Trials Sponsors Conditions Drugs Pricing

Conditions

Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Outcome Measures

Primary Outcomes (1)

Efficacy (in terms of ctDNA clearance) of AZD2936 compared to observation (Standard of Care, SOC) in LA-HNSCC patients who have MRD (MRD+) after definitive treatment.
Clearance of bespoke ctDNA at different time points (week 2 and week 10 after the end of MRD treatment). ctDNA clearance is defined as no detection of ctDNA in both of these two consecutive determinations.
3 years

Secondary Outcomes (4)

Efficacy (in terms of delaying or preventing radiological recurrence of disease or death) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
Efficacy (in terms of MRD control) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
Efficacy (in terms of median DFS and OS) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
Safety and tolerability of AZD2936 in MRD+ LA-HNSCC patients after definitive treatment and randomized to receive this combination.
3 years

Other Outcomes (14)

Predictive value (in terms of predicting radiological recurrence of disease or death) of HPV DNA in patients with HPV positive LA-HNSCC treated with AZD2936 compared to observation (SOC).
3 years
Predictive value (in terms of predicting radiological recurrence of disease or death) of methylated ctDNA in MRD+ LA-HNSCC patients treated with AZD2936 compared to observation (SOC).
3 years
Kinetics of bespoke ctDNA and HPV DNA in LA-HNSCC patients after definitive therapy
2 years
+11 more other outcomes

Study Arms (2)

MRD positive and/or radiological/clinical progression Cohort

EXPERIMENTAL

Dose formulation- AZD2936 is supplied as a liquid drug product in a 20R vial containing 750 mg (nominal) of active AZD2936. The solution contains 50 mg/mL AZD2936 in 20 mM L-histidine/L- histidine-hydrochloride, 240 mM sucrose, 0.04% (w/v) poloxamer 188, at pH 6.0. Unit dose strength(s)- 750 mg/vial (50 mg/mL) Dosage levels- 750mg administered Q3W Route of administration- IV infusion over 1 hour

Biological: AZD2936

MRD negative Cohort

NO INTERVENTION

Observation

Interventions

AZD2936Biological

AZD2936 is a monovalent, bispecific, humanized, IgG1 triple mutant mAb antibody against human PD 1 and TIGIT. AZD2936 was constructed on the backbone of the DuetMab molecule (Mazor et al., 2015), and its antigen binding fragment portions are comprised of the variable domains of the anti TIGIT COM902 antibody and anti PD 1 LO115 antibody. The IgG1 Fc domain carries the triple mutation (L234F/L235E/P331S) designed to reduce Fc mediated immune effector functions. In the preclinical studies, dual blockade of TIGIT and PD 1 by AZD2936 enhanced human T cell function and promoted antitumor immune responses.

MRD positive and/or radiological/clinical progression Cohort

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years at the time of screening or age of consent according to law.
Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
NeoGenomics Laboratories, Inc.
Type not reportedcollaborator
Personalis Inc.

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Canada

RECRUITING

Sawako ElstonCONTACTSawako.Elston@uhn.ca

Study Officials

Lillian Siu, MD
Princess Margaret Cancer Centre
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lillian Siu, MD

CONTACT

416-946-4501 Phase1Ops@uhn.ca

Sawako Elston

CONTACT

Sawako.Elston@uhn.ca

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 10, 2022

Study Start

July 12, 2023

Actual (reported)

Primary Completion

September 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Any of the following would exclude the subject from participation in the study:
Evidence of distant metastasis in staging.
History of allogeneic organ transplantation.
History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to AZD2936 or any of the excipients.
History of active primary immunodeficiency.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], immune related diverticulitis \[prior diverticulitis in the context of diverticulosis is allowed provided is not active\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]).
The following are exceptions to this criterion:
Participants with vitiligo or alopecia
Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 5 years may be included but only after consultation with the Principal Investigator
Participants with celiac disease controlled by diet alone
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen \[HBsAg\] result), or hepatitis C(HCV) or acute hepatitis A. Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Also participants who have chronic hepatitis B and are receiving suppressive antiviral therapy are allowed to be enrolled if ALT is normal and viral load is controlled (\<100 U/ml by polymerase chain reaction). These patients must remain on antiviral therapy as per institutional practice during the study treatment and follow up period to ensure adequate viral suppression. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Patients with a known history of infection with human immunodeficiency virus (positive HIV 1/2 antibodies) are excluded. Testing in patients with no known history or no known risk factors is not required.
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
History of another primary malignancy except for:
+18 more criteria

Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (14)

Study Arms (2)

MRD positive and/or radiological/clinical progression Cohort

MRD negative Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (14)

Study Arms (2)

MRD positive and/or radiological/clinical progression Cohort

MRD negative Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations