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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05419388
Collaborator
(none)
80
Enrollment
3
Locations
2
Arms
38
Anticipated Duration (Months)
26.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Oct 15, 2025
Anticipated Study Completion Date :
Oct 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low dose every three weeks (Q3W)

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Drug: RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Experimental: High dose Q3W

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Drug: RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)]

Secondary Outcome Measures

  1. Percentage of Participants with Adverse Events [Up to 25 months]

  2. Objective response rate (ORR) [Up to 25 months]

  3. Disease control rate (DCR) [Up to 25 months]

  4. Duration of response (DOR) [From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)]

  5. Serum concentration of RO7247669 [Up to 25 months]

  6. Percentage of participants with anti-drug antibodies (ADAs) [Baseline up to 25 months]

  7. Change from baseline in the number and activation status of peripheral blood immune cells [Baseline up to 25 months]

  8. Change from baseline in the number and activation of immune cells in the tumor microenvironment [Baseline to Cycle 2 Day 9 (cycle = 21 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)

  • Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

  • Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status

  • Adequate cardiovascular, hematological, hepatic and renal function

  • Willingness to abide by contraceptive measures for the duration of the study

  • Participants must have known PD-L1 status

Exclusion Criteria:

  • Pregnancy, lactation, or breastfeeding

  • Known hypersensitivity to any of the components of RO7247669

  • Participants must not have ocular melanoma

  • Symptomatic central nervous system (CNS) metastases

  • Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization

  • Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization

  • Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study

  • Active or history of autoimmune disease or immune deficiency with some exceptions

  • Prior systemic anticancer therapy for unresectable or metastatic melanoma

  • Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1[PD-L1]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen [CTLA-4]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies

  • Prior treatment with anti-LAG3 therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Melanoma Institute Australia North Sydney New South Wales Australia 2060
2 Princess Alexandra Hospital; Cancer Trials Unit Woolloongabba Queensland Australia 4102
3 Wellington Hospital; Regional Oncology Unit Wellington New Zealand 6002

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT05419388
Other Study ID Numbers:
  • BP43963
First Posted:
Jun 15, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Aug 23, 2022