Table 4.
Ongoing/upcoming clinical trials testing immunotherapy in BCG refractory BC alone or in combination (recruitment status: NYR: not yet recruiting, ANR: active, not recruiting; R: recruiting; EBRT-B: external beam radiotherapy of the bladder; Q3/6W: 3-/6-weekly; * = Indolamin-2,3-Dioxygenase (IDO) inhibitor; Inst: instillations; ♦ = second treatment arm: BCG naïve patients).
| Trial Name | PREVERT | ADAPT-BLADDER | Check-Mate 9UT | MK-3475-676/ KEYNOTE-676 |
CORE-001 | QUILT-3.032 | ALT-801 in Patients with BCG NMIBC |
|---|---|---|---|---|---|---|---|
| NCT number | NCT03950362 | NCT03317158 | NCT03519256 | NCT03711032 | NCT04387461 | NCT03022825 | NCT01625260 |
| Immune mediating agent | Avelumab 10 mg/kg i.v. Q3W for 8 cycles | Durvalumab 1120 mg i.v. Q3W for 8 cycles | Nivolumab i.v. | Pembrolizumab 200 mg i.v. Q3W or 400 mg i.v. Q6W for 2 years | CG0070 Inst. + Pembrolizumab 200 mg i.v. Q3W |
ALT-803 Inst. | ALT-801 i.v. |
| Molecular mechanism of action | Anti-PD-L1 antibody | Anti-PD-L1 antibody | Anti-PD-1 antibody | Anti-PD-1 antibody | Oncolytic virus + Anti-PD-1 antibody |
IL-15RαFc superagonist | T-cell receptor -interleukin-2 fusion molecule |
| In combination with | EBRT-B with 60–66 Gray in 30–33 fractions | Mono or + BGC Inst. or + EBRT-B | Mono or + BGC Inst. or + Linrodostat (BMS-986205) * or + both | BCG Inst. | - | BGC Inst. | Gemcitabine i.v. |
| Treatment arms | 1 | 3 | 4 | 2 ♦ | 1 | 1 | 1 |
| Study phase | 2 | 1/2 | 2 | 3 | 2 | 2/3 | 1b/2 |
| Histology | CIS or TaT1/HG or both | CIS or TaT1/HG or both | CIS+/−TaT1/HG | CIS or TaT1/HG or both | CIS+/−pTa/T1 HG | CIS+/−TaT1/HG | CIS or TaT1/HG or both |
| Trial status | NYR | R | ANR | R | R | R | ANR |