Clinical trial · Interventional
Nivolumab in Relapsed Pediatric Solid Tumors
A Phase I/II Clinical Trial of Nivolumab in Progressive/Relapsed Pediatric Solid Tumors
- 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)
patients with progressive/relapsed solid tumors who failed first line therapy , will be treated biweekly with the anti PD1- Nivolumab. at least one month after treatment initiation low dose cyclophosphamide will be started . patients on trial will submit tissue and blood tests for whole exome an immune genomic signature. patients will also undergo repeated immunophenotype as part of follow up.
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 |
|---|---|---|---|
| Antibodies, Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab,low dose cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- progressive/relapsed solid tumors
- description
- patient with progressive/relapsed solid tumors who failed first line therapy
- interventionNames
- Drug: Nivolumab,low dose cyclophosphamide
Primary outcomes (2)
- measure
- Event free survival
- timeFrame
- 6 months
- description
- Rate of patients with stable disease/tumor response at 6 months
- measure
- Overall survival
- timeFrame
- 6 and 12 months
- description
- Rate of patients alive at 6 months and 12 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
1. Ages Eligible for Study: 12 Months and older
2. Patients must have had histologic verification of malignancy at original diagnosis or relapse
Eligible pathologies:
1. neuroblastoma following lack of complete response to at least two lines of therapy
2. rhabdomyosarcoma following progression after first line therapy
3. Ewing sarcoma following progression after second line of therpy
4. Osteosarcoma following progression after first line of therapy all other pathologies will be discussed with PI
3. Patients must have measurable disease
4. Patient's current disease state must be one for which there is no known curative therapy
5. Karnofsky \>= 50 for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
6. Patients must have fully recovered from the acute toxic effects of all prior anti-cancer treatment
1. At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
2. At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
3. at least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
7. Blood counts recovery including ANC \>= 750/mm\^3 and Platelet count \>= 50,000/mm\^3
8. Creatinine clearance ≤ 1.5 ULN
9. liver function:Total bilirubin ≤ 2 ULN, ALT or AST ≤ 2.5 ULN (or \< 5 in case of liver impairment)
10. Life expectancy of at least 4 months
11. Pregnancy:
1. Negative pregnancy test in women of childbearing potential
2. Use of an effective contraceptive method during the whole treatment and
3. up to 3 months after the completion of treatment in males and females
12. prior informed consent signed
Exclusion Criteria:
1. Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
2. Patients who are currently receiving another investigational drug are not eligible
3. Patients who are currently receiving other anti-cancer agents are not eligible
4. Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody \[ANA\], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
5. Patients with \>= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
6. Patients who have an uncontrolled infection are not eligible.
7. Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment.References
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