A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Feb 2023 → 27 Nov 2025

Decision date (initial)

2024-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

F. Hoffmann-La Roche Ltd

External identifiers

EU CT number

2023-505672-30-00

EudraCT number

2022-000631-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Pharmacodynamic, Safety, Efficacy

To evaluate the clinical activity of RO7247669 at 600 mg and 1200 mg every 3 weeks (Q3W) on the basis of progression-free survival (PFS)

Secondary objectives 6

1. 1. To evaluate the safety and tolerability of RO7247669 at 600 mg and 1200 mg Q3W
2. 2. To evaluate the clinical activity of RO7247669 at 600 mg and 1200 mg Q3W on the basis of objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) for participants with objective response
3. 3. To investigate the pharmacokinetics (PK) of RO7247669 at 600 mg and 1200 mg Q3W
4. 4. To evaluate the immune response after administration of RO7247669 at 600 mg and 1200 mg Q3W
5. 5. To evaluate potential effects of anti-drug antibodies (ADAs)
6. 6. To assess treatment-induced pharmacodynamic changes (PD biomarkers) in peripheral blood and tumor microenvironment

Conditions and MedDRA coding

Unresectable or Metastatic Melanoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
2. 2. Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
3. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
4. 4. Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
5. 5. Adequate cardiovascular, hematological, hepatic and renal function.
6. 6. Participants must have known PD-L1 status

Exclusion criteria 6

1. 1. Pregnancy, lactation, or breastfeeding
2. 2. Participants must not have ocular melanoma
3. 3. Symptomatic central nervous system (CNS) metastases.
4. 4. Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
5. 5. Active or history of autoimmune disease or immune deficiency with some exceptions
6. 6. Prior systemic anticancer therapy for unresectable or metastatic melanoma

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. PFS defined as the time from randomization to the first occurrence of progression as determined by the Investigator according to RECIST v1.1 or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first

Secondary endpoints 9

1. 1. Nature, frequency, and severity of AEs graded according to the NCI CTCAE v5.0
2. 2. ORR, defined as the proportion of participants with an objective response (i.e., complete response [CR] or partial response [PR]), according to RECIST v1.1
3. 3. DCR, defined as ORR + stable disease rate (SDR)
4. 4. DoR for participants with objective response, defined as the time from the first occurrence of a documented objective response to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
5. 5. Serum concentrations, PK profiles and parameters for RO7247669
6. 6. Incidence and titer of RO7247669 ADAs during the study relative to the prevalence of ADA at baseline
7. 7. Relationship between ADA status and PK, safety, pharmacodynamics, and efficacy
8. 8. Changes from baseline in the phenotype and activation status of T cell subsets in the peripheral blood (CD4/CD8 HLA-DR+/Ki67+)
9. 9. changes from baseline in the tumor microenvironment (such as CD8 T-cell infiltration, proliferation (CD8+Ki67+))

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 5

Locations

5 EU/EEA countries · 8 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

Documents 38 files

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

Application history

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