IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Io Biotech ApS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 May 2022 → 29 Jan 2026

Decision date (initial)

2024-05-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

IO Biotech ApS

External identifiers

EU CT number

2024-511996-13-00

EudraCT number

2021-004594-32

ClinicalTrials.gov

NCT05155254

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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

Secondary objectives 1

1. to further explore the efficacy of IO102-IO103 in combination with pembrolizumab compared with pembrolizumab alone in terms of ORR, OS, DRR, and CRR and to investigate the safety and tolerability of the treatment.

Conditions and MedDRA coding

Previously untreated, unresectable, or metastatic melanoma

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 (90). 2. Patients are treatment naive—that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible: a. Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigators assessment.D ocumented BRAFV600 mutation status must be available from all patients prior to trial entry. b. 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 and if relapse did not occur during active treatment or within 6 months of treatment discontinuation. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1 assessed within 10 days before randomization. 4. Life expectancy of >24 weeks at the time of informed consent per investigator assessment. 5. At least 1 measurable lesion according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions before inclusion. 6. 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. Note: • Use of archival tissue >3 months old, may be considered after communication with and agreement by the Sponsor. • If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor tissue submission can be found in the Lab Manual). For the full list of inclusion criteria, please refer to the protocol.

Exclusion criteria 1

1. 1. Uveal/ocular, acral or mucosal melanoma 2. 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 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. 3. Patient has received previous radiotherapy within 2 weeks of start of trial treatment. 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. 4. 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. 5. Active known or suspected autoimmune disease that has required systemic treatment in the past 2 years. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 6. Presence of other primary malignancies, with the exception of non-melanoma skin cancer, carcinoma in situ or stage I nonulcerative melanoma, in situ cervical cancer, in situ breast cancer and prostate cancer for patients who are receiving androgen deprivation therapy only. Other primary malignancies are only acceptable if there is no ongoing active disease and no biomarker indication of active disease. 7. Active infection requiring systemic therapy 8. History of active tuberculosis For the full list of exclusion criteria, please refer to the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • PFS, defined as the time from randomization to the first documented disease progression (based on Independent Review Committee (IRC) in accordance with RECIST v1.1) or death from any cause. Patients who have not progressed or died at the time of analysis will be censored at the date of assessment from their last disease assessment.

Secondary endpoints 2

1. • Overall Response Rate (ORR) defined as the percentage of patients achieving a confirmed partial response (PR) or confirmed complete response (CR). ORR will be determined by the IRC in accordance with RECIST v1.1.
2. • OS, defined as the time from randomization until death from any cause. Patients not known to have died will be censored at the date they were last known to be alive Etc.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Io Biotech ApS

Sponsor organisation

Io Biotech ApS

Address

Ole Maaloees Vej 3

City

Copenhagen N

Postcode

2200

Country

Denmark

Scientific contact point

Organisation

Io Biotech ApS

Contact name

Medical

Public contact point

Organisation

Io Biotech ApS

Contact name

Medical

Third parties 10

Locations

10 EU/EEA countries · 71 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 131 files

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

Application history

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