An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma

Running, not enrolling · Phase 2

Conditions studied: Meningiomas

In brief

This research study is studying targeted immunotherapies as a possible treatment for recurrent meningioma. The names of the study interventions involved in this study are nivolumab and ipilimumab.

Key facts

Study ID

NCT02648997

Run by

Dana-Farber Cancer Institute

People needed

40

Starts

2016-03-01

Expected to finish

2026-10-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically confirmed WHO grade I, II or III meningioma that is progressive or recurrent. Metastatic meningiomas are allowed. Participants with grade I tumors must have failed radiation therapy.
• Prior therapy:
• There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents.
• Patients may have been treated with standard external beam radiation or radiosurgery in any combination, however, an interval of ≥ 12 weeks (84 days) must have elapsed from the completion of the radiation therapy to start of study therapy unless there is histopathologic confirmation of recurrent tumor or there is new enhancing tumor outside the radiation field (beyond the high dose region or the 80% isodose line).
• In addition, there must be subsequent evidence of tumor progression after completion of radiation therapy (grade I tumors only)
• An interval of ≥ 28 days and full recovery (no ongoing safety issues) from surgical resection
• An interval of ≥ 7 days from stereotactic biopsy;
• For prior systemic agents, participants must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas) or biologic therapies.
• Participants must have recovered to grade ≤ 1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include but are not limited to alopecia, laboratory values listed per inclusion criteria and lymphopenia);
• Be 18 years of age on day of signing informed consent.
• Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A).
• Participants must demonstrate adequate organ and marrow function as defined below (all screening labs to be performed within 14 days of treatment initiation):
• White blood cell (WBC) ≥ 2000/mm3
• Absolute neutrophil count (ANC) ≥ 1,000/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 9 gm/dl
• AST(SGOT)/ALT(SGPT) ≤ 3 x laboratory upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 X ULN OR
• creatinine clearance (meas or calc) ≥ 60 mL/min for participants with creatinine levels > 1.5 X ULN
• (GFR can be used in place of creatinine or creatinine clearance)
• Total serum bilirubin ≤ 1.5 X ULN
• (except participants with Gilbert's Syndrome, who can have a total bili < 5 X ULN)
• Resting baseline oxygen saturation ≥ 92% at rest by pulse oximetry
• MRI (or CT if MRI contraindicated) within 14 days prior to start of study drug. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required.
• Ability to understand and the willingness to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by MRI (or CT), as confirmed by signing a written informed consent document.

You may not qualify if…

• Current or planned participation in a study of an investigational agent or using an investigational device.
• Tumors that are primarily localized to the brainstem or spinal cord;
• Evidence of intratumoral or peritumoral hemorrhage on baseline MRI scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans;
• Prior Therapy:
• Prior treatment with systemic immunosuppressive treatments, aside from systemic dexamethasone therapy for cerebral edema, such as methotrexate, chloroquine, azathioprine, etc. within 3 months of start of study therapy;
• Prior treatment with interstitial brachytherapy within 6 months of start of study therapy;
• All patients: Previous treatment with PD-1 or PD-L1 directed therapy;
• Cohort 2 patients: Previous treatment with CTLA-4 directed therapy;
• Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study;
• Minor surgical procedure (eg, stereotactic biopsy within 7 days of first study treatment; placement of a vascular access device within 2 days of first study treatment);
• Other Meds:
• Participants who are receiving any other investigational agents.
• Immunosuppressive medications / steroids:
• Subject must not require high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks prior to Day 1of study therapy;
• Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).
• Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents.
• A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
• Has received a live vaccine within 30 days prior to the first dose of study drug; seasonal influenza vaccination is permitted excluding the nasal spray formulation;
• No concurrent treatment on another clinical trial. Supportive care trials or non- treatment trials, e.g. quality of life, are allowed;
• Concomitant Medical Illnesses: Uncontrolled intercurrent illness, including-but not limited to:
• Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis;
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results examples include but are not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements;
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, conditions not expected to recur in the absence of an external trigger or resolved childhood asthma/atopy would be exceptions to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study;

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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