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New treatment option for Sarcoma
Official title Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
ClinicalTrials.gov ID: NCT03465592
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma.
Also referred to as BMS-936558, MDX1106.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is being done to find out if an investigational drug, Nivolumab, can be safely administered after a "half-matched" (haplo) bone marrow transplant (BMT), and if the investigational drug will help to prevent or delay relapse or progression of sarcomas. In this study investigators will also be trying to learn more about how the investigational drug changes blood and/or tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 40
You may be able to join if
- Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment.
- Patients with histologically confirmed solid tumors with an estimated poor long term survival.
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age.
- Patients must be post RIC haploidentical BMT.
- Patients must have fully recovered from the acute toxic effects of prior BMT.
You likely can't join if
- GVHD: any history of Stage 4 skin GVHD or Stage 3 gut/liver GVHD (a.k.a. overall Grade III/IV GVHD) or any severe chronic GVHD. Any person with ≤...
- Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active auto- or allo-immune disease
- BMT-related toxicities: patients who developed idiopathic pneumonia syndrome (IPS) or veno-occlusive hepatic disease (VOD) must be off systemic...
- Infection: Patients who have an uncontrolled infection.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Has active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune...
See the full eligibility criteria
- Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment.
- Patients with histologically confirmed solid tumors with an estimated poor long term survival.
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age.
- Patients must be post RIC haploidentical BMT.
- Patients must have fully recovered from the acute toxic effects of prior BMT.
- Concomitant radiation therapy can be administered in the setting of this trial.
- people must consent to allow for a baseline tumor biopsy. If a biopsy is not feasible, then archival tumor material must be made available. Tumor biopsies to be taken (if a subject's tumor is thought to be reasonably...
- Organ Function Requirements: I. Adequate Hematologic Parameters:
- For patients with solid tumors without known bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) ≥ 500/mm3
- Platelet count ≥ 50,000/mm3
- Patients with known bone marrow metastatic disease will be eligible for study without the above criteria. They may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions...
- Creatinine clearance or radioisotope Glomerular filtration rate (GFR) ≥ 70ml/min/1.73 m2 or
- A serum creatinine based on age/gender as follows:
- Age 1 to \<2 years, Male: 0.6 and Female: 0.6
- Age 2 to \<6 years, Male: 0.8 and Female: 0.8
- Age 6 to \<10 years, Male: 1 and Female:1
- Age 10 to \<13 years, Male: 1.2 and Female 1.2
- Age 13 to \<16 years, Male: 1.5 and Female 1.4
- Age ≥ 16 years, Male: 1.7 and Female 1.4 III. Adequate Liver Function Defined as:
- Bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age
- Serum glutamic pyruvic transaminase (SGPT) (ALT) ≤110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
- Patients must have been registered on protocol J12106 "A Phase II Trial of Reduced Intensity Conditioning and HLA-matched or Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplant for...
- GVHD: any history of Stage 4 skin GVHD or Stage 3 gut/liver GVHD (a.k.a. overall Grade III/IV GVHD) or any severe chronic GVHD. Any person with ≤ Grade II GVHD must be off systemic immunosuppressive therapy for at least...
- Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active auto- or allo-immune disease
- BMT-related toxicities: patients who developed idiopathic pneumonia syndrome (IPS) or veno-occlusive hepatic disease (VOD) must be off systemic immunosuppression and/or defibrotide for at least 14 days to be eligible.
- Infection: Patients who have an uncontrolled infection.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Has active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to...
- Allergies and Adverse Drug Reaction
- History of allergy to study drug components.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Pregnancy or Breast Feeding: Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 5 months after the last dose...
The study team makes the final eligibility decision.
Where it's taking place
- St. Petersburg, Florida, United States
- Baltimore, Maryland, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St. Petersburg, Florida, United States; Baltimore, Maryland, United States; The Bronx, New York, United States; Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.