Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
Javelin Medley
Clinical summary
Summary
Eligible participants will be randomised into one of four groups (A-D).
Participants in Group A will receive 800mg of intravenous Avelumab once every two weeks, until toxicity, consent or initiation of new treatment.
Participants in Groups B-D will receive Avelumab in combination with sacituzumab govitecan, M6223 or NKTR-255. Sacituzumab govitecan will be administered intravenously, at a dose of 10mg/kg of body weiht once a week on Day 1 and 8 of a 21-day treatment cycle; M6223 (an anti-T cell-immuno-receptor with Ig and ITM domains) will be administered at a dose of 1600mg once every two weeks, intravenously; and NKTR-255 will be administered intravenously at a dose of 3 micrograms per kilogram of body weight once every four weeks.
Conditions
This trial is treating patients with urothelial cancer
Eligibility
Inclusion
- Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
- Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
- The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
- Estimated life expectancy of at least 3 months
- Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Adequate hematological, hepatic, and renal function as defined in the protocol
- Other protocol defined inclusion criteria could apply
Exclusion
- Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab.
- Participants with active infection 48 hours before randomization requiring systemic therapy
- Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
- Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
- Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered >= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed
- Other protocol defined exclusion criteria could apply
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
EMD Serono
Scientific Title
A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)
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