Clinical trial · Interventional
Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas
Phase II Randomized Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas After One Prior Line of Systemic Therapy or Ineligible to Receive an Anthracycline-based Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patient enrolled as new similar study will be in system within 3 months
Summary
Brief summary (as posted)
This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab
- description
- Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
- interventionNames
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Nivolumab with Pazopanib
- description
- Pazopanib at a dose of 800mg by mouth daily.
- interventionNames
- Biological: Nivolumab
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of metastatic or unresectable soft tissue or bone sarcoma * No prior therapy with nivolumab in either cohorts or with pazopanib in the combination cohort * At least one line of systemic therapy or ineligibility for an anthracycline based chemotherapy * At least 2 distinct measurable metastatic sites * Adequate organ and marrow function as defined by initial laboratory tests * Life expectancy \> 3 months * Stable brain metastases for at least 4 weeks and no steroid dependence Exclusion Criteria: * Autoimmune disease Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drugs hazardous or obscure the interpretation of adverse events * Concomitant therapy with any non-study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigation therapies Chronic use of systemic corticosteroids greater than prednisone 10 mg daily or its equivalent * Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 5 months after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding; * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness.
References
Publications (0)
Data not yet available