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

Phase 2

Recruiting

• Conditions: Melanoma; Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: IO102-IO103; Drug: Pembrolizumab KEYTRUDA®

• Registration Number: NCT05280314
• Lead Sponsor: IO Biotech

Brief Summary

This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.

Detailed Description

This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. Approximately 60 patients with melanoma or SCCHN will be included (approximately 15 for each indication).During the neoadjuvant period, patients in cohort A, cohort B and Cohort C (Arm A) will receive IO102-IO103 and pembrolizumab KEYTRUDA® Q3W. Patients in Cohort C (Arm B) will receive pembrolizumab KEYTRUDA® Patients with melanoma will receive 3 doses of neoadjuvant treatment. Patients with SCCHN will receive 2 or 3 doses of neoadjuvant treatment, at the investigator's discretion. Surgical resection will be performed 1 to 3 weeks after the last dose of neoadjuvant treatment. All patients in cohort A,B and Cohort C (Arm A)will receive post-surgery treatment with IO102-IO103 and pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks). Patients in Cohort C (Arm B) will receive post-surgery treatment with pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks).

Patients with melanoma and patients with SCCHN who do not require SOC RT ± cisplatin will start post-surgery treatment after adequate recovery from surgery (approximately 1 to 2 months; no more than 12 weeks).Patients with SCCHN who require postoperative SOC therapy after surgery will start post-surgery IO102-IO103 and pembrolizumab KEYTRUDA® after adequate recovery from SOC therapy (approximately 1 to 2 months; no more than 12 weeks).

Objective response will be based on imaging; pathologic tumor response of the surgical specimens will be assessed at the time of surgery. Safety will be assessed by recording adverse events. The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment. Secondary endpoints include disease-free survival (DFS) at 2 years after surgery. All patients will have an end-of-treatment visit approximately 4 weeks after their last dose of trial treatment. Follow-up visits will be conducted at 6 and 12 months after the end-of-treatment visit. Following completion of the 12-month follow-up period, long-term follow-up for overall survival (OS) will be conducted every 6 months for at least a further 12 month.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Study Start: 2023-12-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-04-30
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A - Melanoma	IO102-IO103	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.
Cohort B - SCCHN	IO102-IO103	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.
Cohort B - SCCHN	Pembrolizumab KEYTRUDA®	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.
Cohort C	IO102-IO103	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)
Cohort A - Melanoma	Pembrolizumab KEYTRUDA®	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.
Cohort C	Pembrolizumab KEYTRUDA®	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)

Primary Outcome Measures

Name	Time	Method
Major pathologic response	Observed in the resected tumor tissue after neoadjuvant treatment at surgery	Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)

Secondary Outcome Measures

Name	Time	Method
Pathologic complete response	Observed in the resected tumor tissue after neoadjuvant treatment at surgery	Pathologic complete response (pCR) (0% residual viable tumor)
Pathologic tumor response	Pathologic tumor response of the surgical specimens will be assessed at the time of surgery.	Pathologic tumor response (≤ 49% residual viable tumor) at surgery
Objective response rate	Determined after 9 weeks of treatment	Objective response rate (ORR), determined by RECIST 1.1
Disease-free survival	at 2 years after surgery	Disease-free survival (DFS) from the date of surgery
Event-free survival	at 2 years after surgery	Event-free-survival (EFS)

Trial Locations

Locations (15)

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Copenhagen University Hospital Herlev; 🇩🇰 Copenhagen, Denmark

Hospital Clínico Universitario de Valencia -INCLIVA; 🇪🇸 Valencia, Spain

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

CHRU Lille; 🇫🇷 Lille, France

Institut Gustave Roussy; 🇫🇷 Paris, France

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Universitätsklinikum Essen & Research Alliance Ruhr; 🇩🇪 Essen, Germany

Universität Heidelberg, Medizinische Fakultät; 🇩🇪 Heidelberg, Germany

Hôpital Ambroise-Paré; 🇫🇷 Paris, France

Hospital Universitario Quirón Dexeus; 🇪🇸 Barcelona, Spain

Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Yale; 🇺🇸 New Haven, Connecticut, United States