Table 3. Clinical trials on novel treatments in testicular germ cell tumours.
| Category | Drug | Phase | Patients enrolled (evaluable) |
Relative risk | Progression- free survival |
Overall survival |
Patient selection |
ClinicalTrials. gov Identifier |
Reference | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| TKI | ||||||||||
| PDGFR/VEGFR | Sunitinib | II | 10 | CR/PR 0% SD 50% |
- | - | Unselected | NCT00453310 | 46 | Completed |
| II | 33 (32) | PR 9% SD 41% |
mPFS 2.0 months |
mOS 3.8 months |
Unselected | NCT00371553 | 45 | Completed | ||
| II | 5 | - | 12-week PFS: 20.0% |
- | Unselected | NCT00912912 | 47 | Terminated (slow accrual) |
||
| PDGFR/VEGFR/ FGFR/c-KIT |
Pazopanib | II | 43 | PR 4.7% SD 44.2% |
3-month PFS 12.8% mPFS 2.5 months |
1-year OS 28.5% mOS 5.3 months |
Unselected | NCT01743482 | 44 | Completed |
| PDGFR/VEGFR/RAF/ c-KIT |
Sorafenib | II | 18 | CR/PR 0% SD 3/18 (>1 year) |
- | - | Unselected | NCT00772694 | 48 | Completed |
| MET | Tivantinib | II | 27 (25) | CR/PR 0% SD 20.0% |
12-week PFS 21% mPFS 1 month |
mOS 6 months |
Unselected | NCT01055067 | 49 | Completed |
| c-KIT, BCR-ABL, PDGFR |
Imatinib | II | 6 | CR/PR 0% | - | - | Selected | - | 50 | Terminated |
| II | 7 | CR/PR/SD 0% | - | - | Selected | - | 51 | Terminated | ||
| Anti CD30 | ||||||||||
| Brentuximab | II | 9 | CR 11.1% PR 11.1% SD 22.2% |
3-month PFS 22.2% mPFS 1.5 months |
6-month OS 77.8% mOS 8.0 months |
Selected | NCT01851200 | 52 | Completed | |
| II | 7 | CR 14.3% PR 14.3% SD 42.8% |
- | - | Selected | NCT01461538 | 53 | Completed | ||
| II | 18 | - | - | - | Selected | NCT02689219 | - | Terminated | ||
| mTOR inh | ||||||||||
| Everolimus | II | 15 | CR/PR 0% | 12-week PFS 40.0% mPFS 1.7 months |
mOS 3.6 months |
Unselected | NCT01466231 | 54 | Terminated | |
| Everolimus | II | 25 (22) | CR/PR 0% | 12-week PFS 0% mPFS 7.4 weeks |
mOS 8.3 weeks |
Unselected | NCT01242631 | 55 | Completed | |
| Sirolimus + erlotinib |
II | 4 | - | - | - | Unselected | NCT01962896 | 56 | Terminated (low accrual) |
|
| PARP inh | ||||||||||
| Olaparib | II | 18 | CR/PR 0% SD 27.8% |
12-week PFS 27.8% |
12- month OS 27.8% |
Unselected | NCT02533765 | 57 | Active | |
| Veliparib + carboplatin + gemcitabine |
II | - | - | - | - | Unselected | NCT02860819 | - | Active | |
| CDK inh | ||||||||||
| Palbociclib | II | 30 (29) | CR/PR 0% | 24-week PFS: 28% mPFS 11 weeks |
- | Selected | NCT01037790 | 58,59 | Completed | |
| Ribociclib [teratoma] |
II R | 10 (8 ribociclib : 2 placebo) |
CR/PR 0% | 24-month PFS 71% ribociclib 0% placebo |
- | Unselected | NCT02300987 | 60 | Terminated (low accrual) | |
| Ribociclib [teratoma] |
II | - | - | - | - | Selected | NCT02187783 | Completed | ||
| Hypo-methylation | ||||||||||
| DNMT | Guadecitabine + cisplatin |
I | 14 | ORR 23% | mPFS 1.7 months |
mOS 7.8 months |
Unselected | NCT02429466 | 61 | Completed |
| DNMT | Guadecitabine + cisplatin + gemcitabine |
Ia | 2 | - | - | - | Unselected | 62 | Completed | |
| Immunotherapy | ||||||||||
| PDL1 | Avelumab | II | 8 | CR/PR 0% | 12-week PFS: 0% mPFS 0.9 months |
mOS: 2.7 months | Unselected | NCT03403777 | 63,64 | Terminated |
| PDL1 | Atezolizumab | II | - | - | - | - | Unselected | NCT02458638 | - | Completed |
| PDL1 + CTLA 4 | Durvalumab + tremelimumab |
II | - | - | - | - | Unselected | NCT03158064 | - | Recruiting |
| PDL1 + CTLA 4 | Durvalumab +/− tremelimumab |
II R | 22 | - | - | - | Unselected | NCT03081923 | 65 | Recruiting Durvalumab monotherapy closed to accrual |
| PD1 | Pembrolizumab | II | 12 | CR/PR 0% SD 16.7% |
- | - | Unselected | NCT02499952 | 66 | Terminated |
| PD1 | Pembrolizumab | II | 12 | - | - | Unselected | NCT02721732 | 67 | Recruiting | |
| PD1 + CTLA 4 | Nivolumab +/− ipilimumab |
II | - | - | - | Unselected | NCT02834013 | 68 | Recruiting | |
| PD1 + CTLA 4 | Nivolumab + ipilimumab x 4 -> nivolumab maintenance |
II | 5 | CR/PR 0% SD 20.0% |
- | - | Unselected | NCT03333616 | 69 | Recruiting |
| PD1 + VEGFR/MET + CTLA 4 |
Nivolumab + cabozantinib +/− ipilimumab |
I | 5 | CR/PR 0% | - | - | Unselected | NCT02496208 | 70 | Recruiting |
| Other targets | ||||||||||
| Claudin 6 | ASP1650 | II | - | - | - | - | Unselected | NCT03760081 | 71 | Completed |
| B-RAF/MEK | Dabrafenib + trametinib |
II | - | - | - | - | Selected | NCT02034110 | 72 | Active |
| ALDH | Cisplatin + disulfiram |
II | - | - | - | - | Unselected | NCT03950830 | Recruiting |
aSGI-110 with cisplatin and gemcitabine chemotherapy in patients with bladder cancer (EudraCT: 2015-004062-29). CR, complete response; mOS, median overall survival; mPFS, median progression-free survival; PFS, progression-free survival; PR, partial response; SD, stable disease.