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Tests treatment safety and results for Melanoma
Official title Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
ClinicalTrials.gov ID: NCT04572451
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 melanoma.
Also referred to as Opdivo®, Anti-PD-1.
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
- Nivolumab (and other agents affecting the anti-programmed death-1 [anti-PD-1] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- SAFETY COHORT
- Patients with advanced/metastatic/unresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up...
- Patients with 1-4 tumor sites that can be irradiated safely
- Age \> or equal 18 years
- ECOG performance status 0 or 1
You likely can't join if
- Known or suspected CNS metastases, with the following exceptions: a) people with controlled brain metastases will be allowed to enroll. Controlled...
- Medical History and Concurrent Diseases
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253
- people with an active, known or suspected autoimmune disease. people with type I diabetes mellitus, hypothyroidism only requiring hormone...
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: i. Myocardial infarction (MI) or...
See the full eligibility criteria
Who can join
- SAFETY COHORT
- Patients with advanced/metastatic/unresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up approximately 30% of total cohort.
- Patients with 1-4 tumor sites that can be irradiated safely
- Age \> or equal 18 years
- ECOG performance status 0 or 1
- Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3000/mcL;
- absolute neutrophil count ≥ 1500/mcL;
- Platelets ≥ 100,000/mcL;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;
- Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)
- Serum creatinine ≤ 1.5 × ULN Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and...
- Ability to understand and the willingness to sign a written informed consent document.
- Reproductive status
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study...
- Women must not be breastfeeding.
- WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days...
- WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of...
- how well it works COHORT
- Patients with anti-PD1/PDL1 refractory melanoma
- Patients with 1-4 tumor sites that can be irradiated safely
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Patients must have normal organ and marrow function as defined above for safety cohort
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions)...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Known or suspected CNS metastases, with the following exceptions: a) people with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least...
- Medical History and Concurrent Diseases
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253
- people with an active, known or suspected autoimmune disease. people with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: i. Myocardial infarction (MI) or stroke/transient ischemic attack (TIA) within the 6 months prior to consent ii...
- A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- people with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those...
- Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse...
- people with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- people with endocrinopathy which is adequately controlled with hormone replacement therapy are an exception to this criterion and may qualify for the study.
- If subject underwent major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially...
- A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with...
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment...
- people who are unable to undergo venipuncture and/or tolerate venous access
- Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy
- people who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)
- Prisoners or people who are involuntarily incarcerated
- people who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- Inability to comply with restrictions and prohibited activities and treatments
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Pittsburgh, Pennsylvania, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Pittsburgh, Pennsylvania, 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.