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A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

ConditionsMetastatic Urothelial CarcinomaMetastatic Urothelial Carcinoma (UC)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics

About this trial

A Randomized, Open-Label, Multicenter, Phase 2/3 Clinical Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years and older

ECOG 0-1

Life expectancy ≥ 6 months

Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component

Disqualifiers

Locally advanced disease that is resectable or suitable for local therapy with curative intent.

Tumors containing any small cell or neuroendocrine differentiation

Ongoing sensory or motor neuropathy Grade 2 or higher.

Radiographic findings consistent with a high risk of bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab Dose 1

    Drug

    First ivonescimab dose to be tested in Phase 2

  • enfortumab vedotin (EV)

    Drug

    Standard of care therapy

  • Pembrolizumab

    Drug

    200 mg

  • Ivonescimab Dose 2

    Drug

    Second Ivonescimab dose to be tested in Phase 2 part of the study

  • Ivonescimab RP3D

    Drug

    Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: Phase 2: Arm AExperimental treatment 2 interventions
Group B: Phase 2: Arm BExperimental treatment 2 interventions
Group C: Phase 3: Arm 1Experimental treatment 2 interventions
Group D: Phase 3: Arm 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Phase 2 Primary Outcome Measure

Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment

Time frame
Through 90 days after the last study treatment
2

Phase 2 Primary Outcome Measure

Number of participants with clinical laboratory abnormalities

Time frame
From first dose until approximately 30 days after the last study treatment, assessed up to 3 years
3

Phase 2 Primary Outcome measure

Objective response rate (ORR)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
4

Phase 2 Primary Outcome Measure

PK characteristics: ivonescimab serum concentration profiles

Time frame
From first dose until end of treatment, assessed up to 3 years

Secondary outcomes

1

Phase 2 Secondary Outcome Measure

PFS per RECIST v1.1 by investigator

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
2

Phase 2 Secondary Outcome Measure

Overall Survival (OS)

Time frame
From date of randomization until the end of study, assessed up to 4 years
3

Phase 2 Secondary Outcome Measure

Duration of Response (DOR)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
4

Phase 2 Secondary Outcome Measure

Incidence of anti-drug antibodies (ADA) against ivonescimab

Time frame
From time of initiation of first dose to 30 days after end of treatment.

Other outcomes

Sponsors and contacts

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

Summit Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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