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
Verified date | November 2022 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. | Innovent Biologics (USA), Inc. |
United States, Australia, France, Germany, Spain, Switzerland, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02506153 -
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
|
Phase 3 | |
Not yet recruiting |
NCT06391099 -
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
|
N/A | |
Recruiting |
NCT06265285 -
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
|
Phase 2 | |
Recruiting |
NCT05098210 -
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04511013 -
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
|
Phase 2 | |
Recruiting |
NCT04812470 -
Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases
|
Phase 1 | |
Not yet recruiting |
NCT05903937 -
Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases
|
Phase 1 | |
Recruiting |
NCT04375527 -
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
|
Phase 2 | |
Terminated |
NCT01271907 -
Drosophila-generated CTL
|
Phase 2 |