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Monoclonal Antibodies

Cohort C for Squamous Cell Carcinoma

Q: What is the participant quota for this research endeavor?

<p>In order to conduct this trial, Merck Sharp &#x26; Dohme LLC requires 30 participants who meet the established inclusion criteria. The research will be conducted through multiple centres, including Copenhagen University Hospital Herlev in Copenhagen and Hospital Universitario Quirón Dexeus in Barcelona.</p>

Phase 2

Recruiting

Led By Barbara Burtness, MD, Prof

Research Sponsored by IO Biotech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

• Stage III or IVA resectable locoregionally advanced SCCHN of the oral cavity, oropharynx (with known HPV-negative or p16-negative status assessed per institution standard or centrally), hypopharynx, or larynx.

ECOG performance score status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up determined after 9 weeks of treatment

Awards & highlights

Study Summary

This trial looks at combining two treatments to fight cancer before and after surgery. It involves patients with resectable tumors in two or more areas.

Who is the study for?

This trial is for adults with certain types of resectable tumors, including oral squamous cell carcinoma and melanoma. Participants must be willing to provide tissue samples, undergo tumor biopsies and imaging tests, have a performance status score of 0 or 1 (which indicates they are fully active or restricted in physically strenuous activity but ambulatory), and have not undergone previous treatments for these conditions.Check my eligibility

What is being tested?

The trial is testing IO102-IO103 combined with pembrolizumab as both pre-surgery (neoadjuvant) and post-surgery (adjuvant) treatment. It aims to assess the anti-tumor effects, safety profile, and how this combination influences immune cells within the tumors across multiple centers.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation in various organs, fatigue, skin reactions at injection sites, flu-like symptoms including fever and chills, changes in blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is in the mouth, throat, or voice box and can be surgically removed.

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I am fully active or can carry out light work.

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My skin cancer is confirmed as stage III melanoma.

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I have melanoma in my lymph nodes from an unknown source.

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I am 18 years old or older.

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My skin cancer has spread to nearby lymph nodes.

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My melanoma has returned and can be surgically removed.

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My melanoma has returned in the lymph nodes close to the original site.

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I am eligible for surgery to remove my cancer with the goal of curing it.

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My skin cancer has spread to several nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ determined after 9 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~determined after 9 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and determined after 9 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major pathologic response

Secondary outcome measures

Disease-free survival

Event-free survival

Objective response rate

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment2 Interventions

Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus intravenous Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B) Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B)

Group II: Cohort B - SCCHNExperimental Treatment2 Interventions

Stage III or IVA resectable locoregionally advanced Squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx (HPV-negative), hypopharynx, or larynx Neoadjuvant Treatment (2-3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.

Group III: Cohort A - MelanomaExperimental Treatment2 Interventions

Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W. Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,086 Total Patients Enrolled

AlmacIndustry Sponsor

3 Previous Clinical Trials

436 Total Patients Enrolled

TheradexIndustry Sponsor

33 Previous Clinical Trials

1,532 Total Patients Enrolled

Frequently Asked Questions

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

Are there multiple research facilities conducting this study within the United States?

"The present medical experiment is enrolling patients from 8 distinct sites, including Copenhagen, Barcelona and Madrid. If you are considering joining the study, it would be prudent to choose a location near your home in order to reduce travel strain."

Answered by AI

Does this research project presently accept participants?

"Affirmative. Evidence posted on clinicaltrials.gov conveys that the trial is presently accepting applicants, which was initially uploaded to the platform by December 31st 2023 and last updated one month later. A total of 30 people between 8 sites are being recruited for participation in this study."

Answered by AI

In what ways can Cohort A - Melanoma be hazardous to individuals?

"Given the amount of evidence available, our team at Power has assigned Cohort A - Melanoma a score of 2 on our safety scale. This is because clinical data exists to support its safety but not efficacy yet due to it being a Phase 2 trial."

Answered by AI

What is the participant quota for this research endeavor?

"In order to conduct this trial, Merck Sharp & Dohme LLC requires 30 participants who meet the established inclusion criteria. The research will be conducted through multiple centres, including Copenhagen University Hospital Herlev in Copenhagen and Hospital Universitario Quirón Dexeus in Barcelona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

2023. "Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280314.

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