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Monoclonal Antibodies

Monalizumab + Cetuximab for Head and Neck Cancer (INTERLINK-1 Trial)

Phase 3
Waitlist Available
Led By Roger B Cohen, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (-28 to -1) through 17.5 months (maximum observed duration)
Awards & highlights

INTERLINK-1 Trial Summary

This trial will test if two drugs are more effective than one drug in treating head and neck cancer.

Who is the study for?
This trial is for adults over 18 with recurrent or metastatic head and neck cancer who have had prior treatments fail, including a PD-(L)1 inhibitor. They should not have used cetuximab unless it was part of curative therapy without progression for at least 6 months. Participants must be in good physical condition (WHO/ECOG status of 0 or 1) and cannot have autoimmune or inflammatory disorders.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Monalizumab plus Cetuximab against a placebo combined with Cetuximab in patients with advanced head and neck cancer. It's randomized, meaning participants are randomly assigned to groups, double-blind so neither researchers nor participants know who gets which treatment, and conducted globally across multiple centers.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, skin rash due to Cetuximab, fatigue, nausea, as well as increased risk of infections from immune system suppression by Monalizumab.

INTERLINK-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (-28 to -1) through 17.5 months (maximum observed duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (-28 to -1) through 17.5 months (maximum observed duration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set
Secondary outcome measures
Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set
Duration of Response Per RECIST 1.1 in FAS
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
+8 more

INTERLINK-1 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2Experimental Treatment2 Interventions
Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Group II: Placebo Q2W + Cetuximab 400 mg/m^2Active Control2 Interventions
Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Monalizumab
2019
Completed Phase 2
~250
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,912 Total Patients Enrolled
Innate PharmaIndustry Sponsor
27 Previous Clinical Trials
2,671 Total Patients Enrolled
Dario Ruscica, MDStudy DirectorAstraZeneca, Cambridge, UK

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04590963 — Phase 3
Squamous Cell Carcinoma Research Study Groups: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2, Placebo Q2W + Cetuximab 400 mg/m^2
Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04590963 — Phase 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04590963 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When did the FDA approve Monalizumab?

"Monalizumab is considered safe based on the amount of data gathered from Phase 3 trials."

Answered by AI

Are there many hospitals running this trial in the city?

"Right now, there are 20 active sites that are looking for patients to enroll in this study. Some of these sites are located in Houston, Las Vegas, and Westwood. If you decide to participate in this trial, you should try and choose a site that is close to minimize travel."

Answered by AI

Are people of all ages allowed to participate in this clinical trial?

"This particular study is only open to applicants that are between 18-130 years old. Out of the 2866 total clinical trials, 83 are for patients younger than 18 and Answer: The purpose of this study is to research the efficacy of psilocybin in treating major depressive disorder.Rewritten Answer: The aim of this study is to investigate whether or not psilocybin is an effective treatment for major depressive disorder."

Answered by AI

What are the most common reasons that doctors prescribe Monalizumab?

"Monalizumab is frequently used as an intervention for pharmacotherapy. Additionally, it is approved for treatment of several other conditions, including regionally advanced squamous cell carcinoma of the head and neck, metastatic squamous cell carcinoma of the head and neck (hnscc), squamous cell carcinoma."

Answered by AI

Are there other similar research projects to Monalizumab?

"At the moment, there are 142 ongoing clinical trials investigating Monalizumab. Of these, 32 are in Phase 3. Although several of the trials for Monalizumab are taking place in Dresden and Arizona, there are actually 6,267 locations running studies for Monalizumab."

Answered by AI

To be eligible for this research, who must participants be?

"This study is looking for 369 participants with oral squamous cell carcinoma between the ages of 18 and 130. To be eligible, applicants must meet the following criteria: Are aged 18 years and over, World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), (oral cavity, oropharynx, hypopharynx, or larynx) which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy, Has measurable disease per"

Answered by AI

Are there still patients needed for this experiment?

"Unfortunately, this study is not currently seeking participants, as indicated by the clinicaltrials.gov website. The study was first posted on October 2, 2020 and was last edited on October 21, 2020. However, there are 2,887 other trials that are open for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
2020. "Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590963.
~82 spots leftby Apr 2025
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