Unresectable Cutaneous MelanomaPhase 1/2NCT05572463
A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
A Phase 1/2 study testing Sintilimab + IBI110 in people with Unresectable Cutaneous Melanoma and Metastatic Cutaneous Melanoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 13 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Cutaneous Melanoma, Metastatic Cutaneous Melanoma
- What is being tested?
- Sintilimab + IBI110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 1 Nov 2022to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 18 years or older
- Histologically confirmed unresectable or metastatic cutaneous melanoma
- Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent
- Available tumor tissue OR be willing to provide a fresh tumor biopsy
- Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
- Adequate organ and bone marrow function
Who cannot join
- Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products
- Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials
- Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1
- Known symptomatic/active untreated central nervous system (CNS) metastasis
- Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy
- Inadequate recovery from all recent surgeries
Show all 19Show fewer
- At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery
- Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study)
- History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load)
- Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody)
- Documented history or current diagnosis of clinically significant cardiac disease
- History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy
- Received solid organ or bone marrow transplantation
- History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease
- 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
- Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose
- Active gastrointestinal (GI) bleeding or GI perforation or fistula
- Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry
- 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
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
United States3 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of California San Francisco Medical Center
San Francisco, California, 94143
France2 sites
Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie
Lyon, 69002
Hospital Saint Louis
Paris, 75010
Germany2 sites
Universitatsklinikum Carl Gustav Carus
Dresden, 01307
Universitatsklinikum Essen
Essen, 45147
Spain2 sites
Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona
Barcelona, 8916
Hospital Universitario Reina Sofia, Cordoba
Córdoba, 14004
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust (Oxford)
Cambridge, CB2 0QQ
Lancashire Teaching Hospitals (Preston)
Preston, PR2 9HT
About this study
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
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.
Read the detailed 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.
- Being tested
- Sintilimab + IBI110
- Keywords
- Neoplasms, Melanoma, Malignant Melanoma
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab + IBI110Combination product
Also called Sintilimab (IBI308)
IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | 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). Receives: Combination Product: Sintilimab + IBI110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 28 months
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]
Measured: Day 1 to Day 42
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
Measured: Up to 2 years
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
Measured: Up to 2 years
Secondary outcomes (13)
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
Measured: Up to 4 years
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
Measured: Up to 2 years
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
Measured: Up to 2 years
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
Measured: Up to 4 years
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Overall survival (OS)
Measured: Up to 4 years
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)
Measured: Up to 25 months
To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
Prevalence and incidence of anti-product antibodies (ADA, Nab)
Measured: Up to 25 months
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Duration of response (DOR) by RECIST 1.1
Measured: Up to 4 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time to Response (TTR) by RECIST 1.1
Measured: Up to 2 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Disease control rate (DCR) by RECIST 1.1
Measured: Up to 2 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Progression-free survival (PFS) by RECIST 1.1
Measured: Up to 4 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Overall survival (OS)
Measured: Up to 4 years
To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)
Incidence and severity of AEs and laboratory abnormalities
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Sponsor Strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- An open-label platform study that will allow evaluation of multiple novel IPs. The study will include multiple treatment arms that can be added sequentially or in parallel. There will be a master protocol describing study design elements common to all treatment arms with treatment arms described in the appendices, added through amendments.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biologics (USA), Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572463
- Sponsor's protocol ID
- PLATFORM201
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05572463
- Acronym / sponsor ID
- PLATFORM201
- Keywords
- Neoplasms, Melanoma, Malignant Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biologics (USA), Inc.
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label platform study that will allow evaluation of multiple novel IPs. The study will include multiple treatment arms that can be added sequentially or in parallel. There will be a master protocol describing study design elements common to all treatment arms with treatment arms described in the appendices, added through amendments.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Combination Product: Sintilimab + IBI110Sintilimab 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, age 18 years or older
- Histologically confirmed unresectable or metastatic cutaneous melanoma
- Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent
- Available tumor tissue OR be willing to provide a fresh tumor biopsy
- Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1
Key exclusion criteria (19 listed)
- Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products
- Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials
- Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1
- Known symptomatic/active untreated central nervous system (CNS) metastasis
- Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab + IBI110Also: Sintilimab (IBI308)IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule | Combination product | Treatment Arm 1 |
Primary outcome
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)
Time frame: Up to 28 months
Incidence and severity of Adverse Events (AEs) and laboratory abnormalities
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)
Time frame: Day 1 to Day 42
Incidence of dose-limiting toxicities (DLTs) [only applicable for safety run-in portion]
To identify novel immunotherapy IPs to progress into the expansion part (Selection Part)
Time frame: Up to 2 years
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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)
Time frame: Up to 2 years
ORR by RECIST 1.1
13 secondary outcomes
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Time frame: Up to 4 years
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Time frame: Up to 2 years
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Time frame: Up to 2 years
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Time frame: Up to 4 years
To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
Time frame: Up to 4 years
To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
Time frame: Up to 25 months
To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
Time frame: Up to 25 months
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time frame: Up to 4 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time frame: Up to 2 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time frame: Up to 2 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time frame: Up to 4 years
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Time frame: Up to 4 years
To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)
Time frame: Up to 28 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sintilimab + IBI110 in people with Unresectable Cutaneous Melanoma and Metastatic Cutaneous Melanoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Germany, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 28 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.