A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma

Metastatic Cutaneous Melanoma Clinical Trial

Official title:

A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05572463
• Other study ID #: PLATFORM201
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: November 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.

Description:

This is a Phase 1b/2, randomized, open label, multicenter, platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target mechanisms implicated in resistance to immunotherapy in participants with unresectable or metastatic cutaneous melanoma who have resistance to anti-PD-1/L1 agents. This study will include multiple treatment arms that can be added sequentially or in parallel.

Each arm consists of a selection and expansion part. The selection part is used for evaluation of safety and preliminary efficacy in each arm. The selection part may also include a safety run-in portion for preliminary safety evaluation and dose confirmation prior to proceeding. If the criteria for safety and preliminary efficacy are met, the arm will open for additional enrollment in an expansion phase.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults, age 18 years or older

2. Histologically confirmed unresectable or metastatic cutaneous melanoma

3. Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent

4. Available tumor tissue OR be willing to provide a fresh tumor biopsy

5. Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1

6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1

7. Adequate organ and bone marrow function

Exclusion Criteria:

1. Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products

2. Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials

3. Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1

4. Known symptomatic/active untreated central nervous system (CNS) metastasis

5. Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy

6. Inadequate recovery from all recent surgeries

7. At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery

8. Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study)

9. History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load)

10. Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody)

11. Documented history or current diagnosis of clinically significant cardiac disease

12. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy

13. Received solid organ or bone marrow transplantation

14. History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease

15. Active or previously documented autoimmune disease including but not limited to inflammatory bowel disease, diverticulitis, celiac disease, systemic lupus erythematosus, Wegener syndrome, multiple sclerosis, and vasculitis

16. Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose

17. Active gastrointestinal (GI) bleeding or GI perforation or fistula

18. Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry

19. Pregnant or lactating women or women who intend to get pregnant or lactate during the study and up to 120 days after the end of treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Cutaneous Melanoma
• Skin Neoplasms
• Unresectable Cutaneous Melanoma

Intervention

Combination Product:
• Sintilimab + IBI110
IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule

Locations

Country	Name	City	State
Australia	Princess Victoria Hospital	Woolloongabba	Queensland
France	Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie	Lyon
France	Hospital Saint Louis	Paris
Germany	Universitatsklinikum Carl Gustav Carus	Dresden
Germany	Universitatsklinikum Essen	Essen
Spain	Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona	Barcelona
Spain	Hospital Universitario Reina Sofia, Cordoba	Córdoba
Switzerland	Universitaets Spital Zurich	Zürich
United Kingdom	Cambridge University Hospitals NHS Foundation Trust (Oxford)	Cambridge
United Kingdom	Lancashire Teaching Hospitals (Preston)	Preston
United States	Henry Ford Hospital	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.	Innovent Biologics (USA), Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)	Incidence and severity of Adverse Events (AEs) and laboratory abnormalities	Up to 28 months
Primary	To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)	Incidence of dose-limiting toxicities (DLTs) [only applicable for safety run-in portion]	Day 1 to Day 42
Primary	To identify novel immunotherapy IPs to progress into the expansion part (Selection Part)	Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Up to 2 years
Primary	To evaluate the antitumor efficacy of immunotherapy in partcipants with unresectable or metastatic melanoma that progressed while on prior treatment(s) that included an anti-PD-1/L1 agent. (Expansion Part)	ORR by RECIST 1.1	Up to 2 years
Secondary	To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)	Duration of response (DOR) by RECIST 1.1	Up to 4 years
Secondary	To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)	Time to Response (TTR) by RECIST 1.1	Up to 2 years
Secondary	To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)	Disease control rate (DCR) by RECIST 1.1	Up to 2 years
Secondary	To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)	Progression-free survival (PFS) by RECIST 1.1	Up to 4 years
Secondary	To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)	Overall survival (OS)	Up to 4 years
Secondary	To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)	Pharmacokinetic parameters including, but not limited to area under the concentration -time curve over dosing interval (AUCtau), Maximum observed plasma concentration at steady state (Cmax,ss), and trough plasma concentration at steady state (Ctrough,ss)	Up to 25 months
Secondary	To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)	Prevalence and incidence of anti-product antibodies (ADA, Nab)	Up to 25 months
Secondary	To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)	Duration of response (DOR) by RECIST 1.1	Up to 4 years
Secondary	To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)	Time to Response (TTR) by RECIST 1.1	Up to 2 years
Secondary	To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)	Disease control rate (DCR) by RECIST 1.1	Up to 2 years
Secondary	To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)	Progression-free survival (PFS) by RECIST 1.1	Up to 4 years
Secondary	To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)	Overall survival (OS)	Up to 4 years
Secondary	To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)	Incidence and severity of AEs and laboratory abnormalities	Up to 28 months