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IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

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ClinicalTrials.gov Identifier: NCT05155254
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : April 24, 2023
Sponsor:
Collaborators:
Syneos Health
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
IO Biotech

Study Description
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Brief Summary:

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

Patients will be stratified on the basis of the following factors; Disease stage: Unresectable stage IIID or stage IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.

All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles corresponding to around 2 years of treatment. Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total, corresponding to around 2 years of treatment.

The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.


Condition or disease Intervention/treatment Phase
Metastatic Melanoma Unresectable Melanoma Drug: IO102-IO103 Drug: Pembrolizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomised 1:1 to receive either dual-antigen IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: IO102-IO103 + pembrolizumab

IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles. Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total.

Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.

 Drug: IO102-IO103
IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously

Drug: Pembrolizumab
Pembrolizumab administered intravenously
Active Comparator: pembrolizumab
Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
 Drug: Pembrolizumab
Pembrolizumab administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Approximately 3.5 years ]
    PFS defined as the time from randomization to the first documented disease progression ((based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Approximately 3.5 years ]
    ORR defined as the percentage of patients achieving a confirmed PR or CR. ORR will be determined by an IRC in accordance with RECIST v1.1.

  2. Durable Objective response rate (DRR) [ Time Frame: Approximately 3.5 years ]
    DRR is defined as the percentage of patients achieving a PR or CR > 182 days. This will be determined by an IRC in accordance with RECIST v1.1.

  3. Complete response rate (CRR) [ Time Frame: Approximately 3.5 years ]
    Percentage of patients with a visit response of CR, which will be determined by the IRC in accordance with RECIST v1.1.

  4. Overall survival (OS) [ Time Frame: Approximately 5.5 years ]
    OS defined as the time from randomisation until death from any cause. Patients not known to have died will be censored at the date last known to be alive.

  5. Duration of response (DoR) [ Time Frame: Approximately 3.5 years ]
    DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier) (based on IRC).

  6. Time to response (TTR) [ Time Frame: Approximately 3.5 years ]
    TTR is defined as the time from the date of randomization to the date of first observed PR or CR (based on IRC).

  7. Time to complete response (TTCR) [ Time Frame: Approximately 3.5 years ]
    TTCR is defined as the time from the date of randomization to the date of first observed CR (based on IRC).

  8. Disease control rate (DCR) [ Time Frame: Approximately 3.5 years ]
    DCR is defined as the percentage of patients achieving a PR or CR or SD (based on IRC).

  9. Incidence of e.g. AEs and SAEs (Safety and Tolerability) [ Time Frame: Approximately 3.5 years ]
    Incidence of AEs and SAEs, and treatment related AEs and SAEs. Incidence of AEs causing discontinuation of trial treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy

  2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:

    1. Patients with proto-oncogene B-Raf (BRAFV600) mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigator assessment.
    2. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last dose at least 6 months before inclusion in this trial (randomization), and if relapse did not occur during active treatment or within 6 months of treatment discontinuation.
  3. At least 1 measurable lesion (not a cutaneous lesion) according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC.
  4. Provision of archival (obtained within 3 months), or newly acquired biopsy tissue not previously irradiated, and blood at screening for biomarker assessments. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.

Exclusion Criteria:

  1. Patients with known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease are excluded with the following exception:

    • Patients with controlled (stable) brain metastases will be allowed to enroll (subject to baseline magnetic resonance imaging (MRI) confirmation). Controlled (stable) brain metastases are defined as those with no radiographic progression for at least 4 weeks after radiation and/or surgical treatment at the time of signed informed consent. Patients must have been off steroids for at least 2 weeks before signed informed consent and have no new or progressive neurological signs and symptoms.

  2. Patient has received previous radiotherapy within 2 weeks of start of trial treatment (visit 2). Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  3. Patients with BRAFV600-positive disease who are experiencing rapidly progressing disease and/or have received standard first-line therapy with BRAF and/or MEK inhibitor for unresectable or metastatic disease.

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155254


Contacts
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Contact: Eva Ehrnrooth Chief Medical Officer, MD, PhD +45 30 59 60 91 ee@iobiotech.com
Contact: Anita Vedel Director Clinical Operations, MSc Pharm +45 31 10 97 91 av@iobiotech.com

Locations
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Sponsors and Collaborators
IO Biotech
Syneos Health
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Inge Marie Svane, MD, Prof Institut for Klinisk Medicin, Herlev-Gentofte Hospital; Denmark
More Information
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Responsible Party: IO Biotech
ClinicalTrials.gov Identifier: NCT05155254    
Other Study ID Numbers: IO102-IO103-013 / KEYNOTE-D18
2021-004594-32 ( EudraCT Number )
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IO Biotech:
Metastatic melanoma
Unresectable melanoma
Immunotherapy
 Progression free survival
IO102-IO103
Pembrolizumab
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action