Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Patients With Head and Neck Cancer that has come back or spread to other parts of the body

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Mar 2021 → 29 Oct 2024

Decision date (initial)

2024-06-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2024-511813-39-00

EudraCT number

2019-004770-25

ClinicalTrials.gov

NCT04590963

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Safety, Pharmacogenetic, Pharmacokinetic, Efficacy, Therapy

To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS) in HPVunrelated participants.

Secondary objectives 2

1. To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by: 1. assessment of OS in all randomized participants; 2. assessment of PFS, ORR, DoR 3. assessment of disease-related symptoms, functioning and quality of life 4. characterization of the association between clinical outcome and protein expression in the tumor 5. assessment of safety and tolerability.
2. To investigate PK and immunogenicity of monalizumab

Conditions and MedDRA coding

Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Are aged 18 years and over
2. Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
3. Received treatment using a PD-(L)1 inhibitor
4. Prior platinum failure
5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
6. At least one measurable lesion at baseline that qualifies RECIST 1.1
7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing
8. WHO/ECOG PS of 0 or 1

Exclusion criteria 4

1. Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
2. Had prior cetuximab therapy (unless it was administered in curative LA setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis
4. Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival, defined as the time from the date of randomization until date of death due to any cause.

Secondary endpoints 9

1. Overall survival, defined as the time from the date of randomization until date of death due to any cause
2. PFS is defined as time from randomization until disease progression, per RECIST 1.1 as assessed by the investigator at local site or death due to any cause, whichever occurs first.
3. ORR is defined as the proportion of participants with measurable disease who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1.
4. DoR is defined as the time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.
5. Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits
6. Concentration of monalizumab in the blood
7. Presence of antibodies to monalizumab in the blood
8. Measurement of specific biomarkers in the tumor sample(s)
9. AEs, vital signs, clinical laboratory results, ECGs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications