Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03651271 | Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer | PHASE2 | COMPLETED | 100 | — | — | Oct 17, 2018 | Jun 30, 2023 | Feb 7, 2024 | 6 | United States |
CBR is defined as the percentage of participants who show clinical benefit, defined as obtaining a complete response (CR; disappearance of all target and non-target lesions), partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), or stable disease (SD) for ≥ 6 months, as determined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Percentage of participants in the nivolumab plus ipilimumab ("CD8 low") arm whose tumors convert from CD8 low (\<15%) to CD8 high (\>=15%) as measured by the percentage of tumoral CD8 cells. Participants in the CD8 high arms are not evaluated for this outcome. On-treatment biopsies for the advanced metastatic cancer cohort were scheduled for as early as possible after the 2nd and 4th doses of ipilimumab (Day 2 - 10 of Cycle 2 and Cycle 6, respectively). On-treatment biopsies for the advanced prostate cancer cohort were scheduled for within 3 days (+/-) of the 2nd and 4th doses of nivolumab (Day 22 of Cycle 1 and Cycle 2, respectively).
| Arm | Type | Description |
|---|---|---|
| "Hot" tumors for Advanced Metastatic Cancer | EXPERIMENTAL | Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab. |
| "Cold" tumors for Advanced Metastatic Cancer | EXPERIMENTAL | Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab. |
| "Hot" tumors for Advanced Prostate Cancer | EXPERIMENTAL | Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab. |
| "Cold" tumors for Advanced Prostate Cancer Cohort A | EXPERIMENTAL | Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab. |
| "Cold" tumors for Advanced Prostate Cancer Cohort B | EXPERIMENTAL | Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab. |
| Name | Type | Description |
|---|---|---|
| Nivolumab Monotherapy | BIOLOGICAL | Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity. |
| Nivolumab and Ipilimumab and Combination for Metastatic Cancer | BIOLOGICAL | For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity. |
| Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer | BIOLOGICAL | For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A. |
| Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer | BIOLOGICAL | For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. |
Inclusion Criteria: 1. Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. Male or female participants of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 7 and 5 months, respectively, ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | PHASE1 | TG4001, Avelumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |