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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05572463




Registration number
NCT05572463
Ethics application status
Date submitted
5/10/2022
Date registered
7/10/2022
Date last updated
18/11/2022

Titles & IDs
Public title
A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
Scientific 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
Secondary ID [1] 0 0
PLATFORM201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Cutaneous Melanoma 0 0
Metastatic Cutaneous Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Sintilimab + IBI110

Experimental: Treatment Arm 1 - Sintilimab is a recombinant fully human anti-programmed cell death protein 1 (PD-1) monoclonal antibody, and IBI110 is a recombinant fully human anti-lymphocyte activation gene 3 (LAG3) monoclonal antibody. Sintilimab (IBI308) will be administered intravenously (IV) in combination with IBI110 administered intravenously (IV) every 3-weeks (Q3W).


Combination Product: Sintilimab + IBI110
IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to 28 months
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Day 1 to Day 42
Primary outcome [3] 0 0
To identify novel immunotherapy IPs to progress into the expansion part (Selection Part)
Timepoint [3] 0 0
Up to 2 years
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [1] 0 0
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
Timepoint [6] 0 0
Up to 25 months
Secondary outcome [7] 0 0
To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
Timepoint [7] 0 0
Up to 25 months
Secondary outcome [8] 0 0
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Timepoint [10] 0 0
Up to 2 years
Secondary outcome [11] 0 0
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)
Timepoint [13] 0 0
Up to 28 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Victoria Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
France
State/province [4] 0 0
Lyon
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Dresden
Country [7] 0 0
Germany
State/province [7] 0 0
Essen
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Córdoba
Country [10] 0 0
Switzerland
State/province [10] 0 0
Zürich
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cambridge
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Innovent Biologics (USA), Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05572463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05572463