LIVIGNO-3
Brief summary
Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide. In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Participant has histologically or cytologically confirmed urothelial carcinoma
(i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic
types are allowed if urothelial (transitional cell) is the predominant histology.
- Participant has radiologically documented metastatic disease.
- Participant must have experienced radiographic progression or relapse on checkpoint
inhibitor (anti-programmed cell death protein 1 [PD-1] or anti-programmed
death-ligand 1 [PD-L1]) in the metastatic, adjuvant, or neo-adjuvant setting.
Participant must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.
- Participants eligible for platinum must have received a platinum containing regimen
(cisplatin or carboplatin) in the metastatic, locally advanced, neoadjuvant, or
adjuvant setting. If platinum was administered in the neoadjuvant or adjuvant
setting, participant must have progressed within 6 months of completion of
treatment. Platinum ineligible participants may enroll in this study without
receiving a platinum containing regimen.
- Participant has at least 1 measurable lesion per response evaluation criteria in
solid tumors (RECIST) v1.1 as determined by investigator.
- Life expectancy must be at least 3 months.
Exclusion Criteria:
- Participant has received more than 1 prior chemotherapy regimen for urothelial
cancer in metastatic setting, including chemotherapy agents planned in comparator
arm.
- Platinum based chemotherapy administered in adjuvant or neoadjuvant setting
will count towards this criterion if participant progressed within 6 months of
completion.
- Chemotherapy administered during concurrent chemoradiotherapy for primary
cancer will not count towards this criterion.
- The substitution of carboplatin for cisplatin does not constitute a new regimen
provided no new chemotherapeutic agents were added to the regimen and no
progression was noted prior to the change in platinum.
- Antibody-drug conjugate (ADC) will not count towards this criterion.
- Participant who previously received gemcitabine in combination with platinum in
metastatic setting will be eligible to receive docetaxel or paclitaxel in
comparator arm.
- Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic
setting.
- Has had prior radiation therapy within 28 days prior to first dose of study drug or
who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to
radiotherapy.
- History of additional malignancy or history of prior malignancy, except for
adequately treated basal or squamous skin cancer, or cervical carcinoma in situ
without evidence of disease, or malignancy treated with curative intent and with no
evidence of disease recurrence for 5 years since the initiation of that therapy.
- Prior allogeneic stem cell or solid organ transplantation.
