An exploratory tumor biopsy-driven study to understand the relationship between biomarkers and indicators of clinical response in immunomodulatory treatment naïve unresectable stage III/IV melanoma patients receiving REGN2810 (anti-PD-1)
- Conditions
- melanomaunresectable melanomaskin cancer1002765610040900
- Registration Number
- NL-OMON49259
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Histologically confirmed diagnosis of stage III (unresectable) or stage IV
cutaneous (non-acral lentiginous) with at least 1 lesion that is measurable by
RECIST 1.1 criteria and accessible for biopsies. , 2. Eastern Cooperative
Oncology Group (ECOG) performance status (PS) of 0 or 1 (ECOG PS 1 definition:
Restricted in physically strenuous activity but ambulatory and able to carry
out work of a light or sedentary nature, eg, light house work, office work).,
3. *18 years old, 4. Hepatic function:, a. Total bilirubin *1.5 x upper limit
of normal, b. Transaminases *3 x ULN, c. Alkaline phosphatase (ALP) *2.5 x ULN,
5. Serum creatinine *1.5 x ULN or estimated glomerular filtration rate >50
mL/min/1.73m^2, 6. Bone marrow function:, a. Hemoglobin *9.0 g/dL, b. Absolute
neutrophil count (ANC) *1.5 x 10^9/L, c. Platelet count *75 x 10^9/L, 7.
Willing and able to comply with clinic visits and study-related procedures, 8.
Provide signed informed consent, 9. Able to understand and complete
study-related questionnaires, 10. Anticipated life expectancy >12 weeks
1. Ongoing or recent (within 5 years) evidence of significant autoimmune
disease that required treatment with systemic immunosuppressive treatments,
which may suggest risk for irAEs., 2. Prior treatment with an agent that blocks
the PD-1/PD-L1 pathway., 3. Prior treatment with other immune modulating
anti-cancer agents., 4. Untreated or active brain metastases or spinal cord
compression. , 5. Immunosuppressive corticosteroid doses, 6. History of human
immunodeficiency virus (HIV)., 7. Uncontrolled chronic hepatitis B or C., 8.
History of pneumonitis within the last 5 years., 9. Grade 3 or 4 hypercalcemia
at time of enrollment., 10. Any systematic anticancer treatment,
investigational or standard of care, within 30 days of the initial
administration of REGN2810 or planned to occur during the study period (Patients
receiving bisphosphonates or denosumab are not excluded)., 11. History of
documented allergic reactions or acute hypersensitivity reaction attributed to
antibody treatments., 12. Known allergy to doxycycline or tetracycline, 13.
Concurrent malignancy other than melanoma and/or history of malignancy other
than
melanoma within 3 years of date of first planned dose of REGN2810, except for
tumors
with negligible risk of metastasis or death, such as adequately treated basal
cell
carcinoma (BCC) of the skin, carcinoma in situ of the cervix, or ductal
carcinoma in situ
of the breast, or history of prostate adenocarcinoma treated with curative
intent at least
3 years prior and with undetectable PSA for at least 3 years prior to
enrollment. Patients
with hematologic malignancies (e.g., chronic lymphocytic leukemia, CLL) are
excluded., 14. Any acute or chronic psychiatric problems that, in the opinion
of the investigator, make
the patient ineligible for participation., 15. Patients with a history of solid
organ transplant., 16. Any medical co-morbidity, clinical laboratory finding,
or concomitant medication that, in the opinion of the investigator, renders the
patient an unsuitable candidate for tumor biopsies due to high safety risks.,
17. Any medical co-morbidity, physical examination finding, or metabolic
dysfunction, or clinical laboratory abnormality that, in the opinion of the
investigator, renders the patient unsuitable for participation in a clinical
trial due to high safety risks and/or potential to affect interpretation of
results of the study., 18. Inability to undergo any response assessment by
contrast-enhanced radiologic imaging., 19. Pregnant or breastfeeding women, 20.
Sexually active men or women of childbearing potential who are unwilling to
practice
highly effective contraception prior to the initial dose, during the study, and
for at least 6
months after the last dose. , 21. Prior treatment with idelalisib, 22.
Radiation therapy within 2 weeks prior to enrollment and not recovered to
baseline from
any AE due to radiation., See protocol section 6.2.2. for more detailed
information
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method