West Cancer Center

BLADDER: ADJUVANT: IMMUNOTHERAPY BASED ON MRD: ALLIANCE MODERN

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

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Malignancy

Bladder cancer, urothelial cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Nivolumab and relatlimab

Drug Class

PD-1 agent and LAG3 agent

PI

Brad Somer, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details

Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Variant histology, including neuroendocrine differentiation, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
Patient must have had radical cystectomy and lymph node dissection >= 3 weeks, but =< 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
No evidence of residual cancer or metastasis after cystectomy
Have undergone a radical cystectomy with pathological evidence of urothelial carcinoma of the bladder at high risk of recurrence as described in one of the two scenarios below (i or ii).
- (i) Patients who have not received neoadjuvant cisplatin-based chemotherapy: pT3-pT4* or pT0/x-pT4/N+ on cystectomy and are not eligible for adjuvant cisplatin chemotherapy
  - (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
    - (i) Creatinine Clearance (using Cockcroft-Gault): < 60 mL/min
    - (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade >= 2 audiometric hearing loss
    - (i) CTCAE version 5, grade >= 2 or above peripheral neuropathy
    - New York Heart Association Class III heart failure
    - (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2
  - (i) Patients who are eligible for cisplatin may be candidates if they refuse available adjuvant chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.
    - (i) Patients with pT2N0 urothelial cancer on cystectomy (without prior neoadjuvant chemotherapy) with ctDNA(+) Signatera results based on an assay performed post-cystectomy as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
- (ii) Patients who received cisplatin-based neoadjuvant chemotherapy: ypT2-ypT4 or ypT0/x-pT4/N+ on cystectomy
ECOG PS 0-2
No adjuvant systemic threapy after cystectomy
No prior PD-1/L1 inhibitor or LAG-3 blockade

BLADDER: METASTATIC: PHASE 1: ASPEN-07

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

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Malignancy

Bladder cancer, urothelial carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Evorpacept

Drug Class

Fusion protein blocking CD47-SIRPalpha

PI

Dan Vaena, MD

Sponsor

ALX Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details

Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma. Subjects with urothelial carcinoma with squamous differentiation or mixed cell types are eligible provided that urothelial is the dominant histology. Any element of neuroendocrine or small cell histology are excluded
Must have received prior treatment with a immune checkpoint inhibitor in the locally advanced or metastatic setting
Must have received prior treatment with platinum containing chemotherapy defined as received in the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months of completion OR received treatment with platinum in the locally advanced or metastatic setting
Must have had progression or recurrence during or following recept of most recent therapy
ECOG PS 0-1
Dose escalation cohorts must have available archival or fresh biopsy sample prior to study entry. Others must have tumor accfessible for sequential biopsy and be willing to provide fresh pre-treatment and on-study tumor tissue biopsies
No pre-existing sensory or motor neuropathy Grade >/= 2
No symptomatic or unctrolled CNS metastases
No prior treatment with enfortumab vedotin
No prior treatment with any anti-CD47 or anti-SIRPa agent
No known uncontrolled HBV/HCV/HIV
No other malignancy within 3 years
No active autoimmune disease requiring treatment in last year

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets