mechanism | treatment | Demonstrated benefit and harm | k | | | |
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immune checkpoint inhibition | atezolizumab | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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IMvigor210 | atezolizumab vs nil | | | |
Trial | Treatments | Patients | Method |
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IMvigor210 | Atezolizumab (n=-9) vs. single arm study (n=-9) | Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen | Single-arm study Sample size: -9/-9 Primary endpoint: FU duration: phase 2 |
|
immune checkpoint inhibition | atezolizumab | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
IMvigor211 (IC2/3) | atezolizumab vs chemotherapy | grade 3-4 treatment-related adverse events 0.46 [0.38; 0.58] | | OS 0.87 [0.63; 1.21] median 11.1 months vs. 10.6 months ORR 1.07 [0.66; 1.73] |
Trial | Treatments | Patients | Method |
---|
IMvigor211 (IC2/3) | atezolizumab (n=467) vs. chemotherapy (n=464) | patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen IC2/3 patients as planned as step 1 of the hierarchical testing | open label Parallel groups Sample size: 467/464 Primary endpoint: OS FU duration: sequential testing of IC2/3 population in first then IC1/2/3 population; and finaly all-comers population |
|
immune checkpoint inhibition | atezolizumab | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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IMVIGOR-130 (monotherapy) | atezolizumab vs control | | | |
Trial | Treatments | Patients | Method |
---|
IMVIGOR-130 (monotherapy) | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin (n=-9) vs. Placebo+Gemcitabine+Carboplatin/Cisplatin (n=-9) 3rd arm with Atezolizumab Monotherapy | Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma | open-design Sample size: -9/-9 Primary endpoint: FU duration: |
|
immune checkpoint inhibition | durvalumab | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
durvalumab phase 1/2 | durvalumab vs nil | | | |
Trial | Treatments | Patients | Method |
---|
durvalumab phase 1/2 | durvalumab at 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity (n=-9) vs. (n=-9) | patients with locally-advanced or metastatic urothelial carcinoma of the bladder who had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting | Single-arm study Sample size: -9/-9 Primary endpoint: FU duration: phase 1/2 |
|
immune checkpoint inhibition | nivolumab | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Checkmate 275 | nivolumab vs nil | | | |
Trial | Treatments | Patients | Method |
---|
Checkmate 275 | nivolumab 3 mg/kg intravenously every 2 weeks until disease progression and clinical deterioration, unacceptable toxicity, or other protocol-defined reasons (n=270) vs. (n=-9) | patients with metastatic urothelial carcinoma after platinum therapy | Single-arm study Sample size: 270/-9 Primary endpoint: ORR FU duration: |
|
immune checkpoint inhibition | pembrolizumab | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Keynote 361 monotherapy | pembrolizumab vs chemotherapy | | | | KEYNOTE-052, 2017 | pembrolizumab vs | | | |
Trial | Treatments | Patients | Method |
---|
Keynote 361 monotherapy | pembrolizumab 200 mg every 3 weeks (Q3W) (n=990) vs. chemotherapy alone (n=0) 3 arms: pembrolizumab ± chemotherapy versus chemotherapy | patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma | Sample size: 990/0 Primary endpoint: FU duration: | KEYNOTE-052, 2017 | intravenous pembrolizumab 200 mg every 3 weeks (n=374) vs. (n=-9) | cisplatin-ineligible patients with advanced urothelial cancer who had not been previously treated with systemic chemotherapy | open-design Single-arm study Sample size: 374/-9 Primary endpoint: ORR FU duration: 5 months (median) phase 2, single arm |
|
immune checkpoint inhibition | pembrolizumab | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
KEYNOTE-045, 2017 | pembrolizumab vs chemotherapy | OS 0.73 [0.59; 0.91] median 10.3 months vs. 7.4 months | | PFS 0.98 [0.81; 1.19] |
Trial | Treatments | Patients | Method |
---|
KEYNOTE-045, 2017 | pembrolizumab (n=270) vs. investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine (n=272) | patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy | open-label Parallel groups Sample size: 270/272 Primary endpoint: OS FU duration: |
|