Clinical trial · Interventional
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.
NCT06601296CI-TRIAL-00097139SPARKrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma ( mRCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| OligoProgressive Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMSA101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1
- description
- Only one arm will be maintained in this phase II study with all patients undergoing the following treatment: SOC treatment: Nivolumab 480 mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)
- interventionNames
- Drug: IMSA101
Primary outcomes (1)
- measure
- To evaluate the PFS rate associated with the therapeutic intervention. PFS is defined as the duration of time from initiation of PULSAR/IMSA101 to disease progression as defined by RECIST1.1 or death.
- timeFrame
- Time from initiation of PULSAR/IMSA101 until death from any cause. Follow-up visits to be done every 12 weeks (+/- 1 week) for study duration until patient has progressed. Afterward, subjects to be contacted every 6 months for survival data up to 5 years
- description
- Exact binomial test will be used to test if the lower limit of the 95% confidence interval of the probability of postponing systemic therapy \>9 months will be greater than 30%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have metastatic ccRCC. * Patients must have oligoprogression defined as progression in ≤5 lesions. * All oligoprogression lesions must be suitable for radiation. * Patients must have at least one site of disease that can be safely injected with IMSA101. * Karnofsky Performance Status (KPS) of at least 50%. * Age ≥ 18 years. * Patients must have adequate organ and marrow function within 14 days prior to study entry. * All IMDC risk categories are allowed. Exclusion Criteria: * Patients with progressive ultracentral/central chest lesions will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.