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Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W

ConditionMuscle-invasive Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmerican University of Beirut Medical Center

About this trial

The purpose of this study is to assess the efficacy and safety of adding the immunotherapy Avelumab as a fourth component, alongside tumor removal, chemotherapy, and radiation, to increase the chance of preserving the bladder in the treatment of muscle-invasive bladder cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form (ICF) before any trial related procedures.

Male or female participant with ≥ 18 years of age at time of consenting.

Participant is able and willing to comply with the requirements of trial protocol.

Pathologically (histologically or cytologically) and radiologically confirmed newly diagnosed MIBC (T2-T4 N0 M0) or recurrent previously NMIBC.

Disqualifiers

Participant with non-muscle invasive bladder cancer or Metastatic disease (M1) and/or lymph node positive.

Participant who underwent radical cystectomy or is planned for radical cystectomy.

Histologically confirmed squamous cell carcinoma, micropapillary carcinoma, neuroendocrine carcinoma, adenocarcinoma, or mixed histology.

Participant had received treatment for urothelial carcinoma, with any of the following anti-cancer therapies prior the first dose of trial treatment: systemic chemotherapy, targeted small molecule therapy, or radiation therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maximum TURBT

    Procedure/Surgery

    Total removal of the bladder tumor through TURBT

  • Chemotherapy + Immunotherapy Induction

    Drug

    Chemotherapy: DDMVAC (6 cycles) or Gemcitabine-Cisplatin (4 cycles) Immunotherapy: Avelumab (6 cycles)

  • Radiotherapy

    Radiation

    Hypofractionated radiotherapy: 20 fractions, 55 Grays

  • Immunotherapy Maintenance

    Drug

    Maintenance Avelumab every 2 weeks for 12 months

  • Watchful waiting with supportive care

    Other intervention

    1 year watch and wait

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm A (Maintenance Avelumab)Experimental treatment 4 interventions
Group B: Arm B (W&W)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Efficacy of Avelumab in 2 non-comparative arms

2 years proportion of MIBC bladder preserved participants in each tetra-modality arm.

Time frame
2 years

Secondary outcomes

1

Response rate post-induction

Response rate of participants in each arm following induction chemo/immunotherapy

Time frame
At week 17 (after 4 months of induction)
2

Quality of life

Effect of each tetra-modality arm on the quality of life of participants using the Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) questionnaire; FACT-Bl total score range: 0-156 (higher scores mean worse quality of life)

Time frame
Every 3 weeks (up to 3 months), then every 4 months (up to 1 year)
3

Safety

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

Time frame
During treatment (up to 90 days after end of treatment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University of Beirut Medical Center

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: