Squamous Carcinoma of the Anal Canal MedDRA version: 20.0 Level: LLT Classification code 10002127 Term: Anal canal cancer recurrent System Organ Class: 100000004864
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Men and women 18 years of age or older (or as applicable per local country requirements). 3. Confirmed diagnosis of locally advanced or metastatic SCAC. 4. Participants must have had progression on or after platinum-based therapy unless ineligible for or intolerant of platinum. a. No more than 2 prior lines of systemic therapy for metastatic disease are permitted. b. Participants who are ineligible for platinum must have received at least 1 prior line of systemic therapy. c. Participants receiving platinum-based radiosensitizing chemotherapy are eligible if relapse occurs =65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C. 2. Radiotherapy within 14 days of first dose of study treatment with the following caveats: a. 28 days for pelvic radiotherapy. b. 6 months for thoracic region radiotherapy that is > 30 Gy in 2 Gy fractions. 3. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor). 4. Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor. 5. Participants with laboratory values at screening defined in the protocol. 6. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent. 7. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent). 8. Evidence of interstitial lung disease or active noninfectious pneumonitis. 9. Known active CNS metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 14 days before the first dose of study drug. 10. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization). 11. Active infections requiring systemic therapy. 12. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids) or known allergy or hypersensitivity to any component of INCMGA00012 or formulation components. 13. Participants with impaired cardiac function or clinically significant cardiac disease: a. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy. b. Unstable angina pectoris. c. Acute myocardial infarction = 6 months before study participation. d. Other clinically significant heart disease (ie, = uncontrolled Grade 3 hypertension.) 14. Participant is pregnant or breastfeeding. 15. Participant is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug. 16. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of INCMGA00012 in terms of the overall response rate (ORR) in participants with locally advanced or metastatic SCAC who have progressed after platinum-based chemotherapy.;Secondary Objective: To determine additional measures of clinical benefit, specifically, DOR, DCR, PFS, and OS. To evaluate the safety of INCMGA00012 in participants with previously-treated SCAC. To determine the PK of INCMGA00012 administered to participants with SCAC.;Primary end point(s): ORR, defined as the percentage of participants having a CR or PR, according to RECIST v1.1 as determined by ICR.;Timepoint(s) of evaluation of this end point: Throughout study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): DOR, defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause. DCR, defined as the number of participants maintaining either an ORR or stable disease. PFS, defined as the time from the first dose of study treatment until disease progression by ICR or death due to any cause. OS, defined as the time from the start of therapy until death due to any cause. Safety, determined by the number of participants; the frequency, duration, and severity of AEs; laboratory tests; vital signs; and ECGs. Population PK, including Cmax, Tmax, Cmin, and AUC0-t, will be summarized. ;Timepoint(s) of evaluation of this end point: Through out study | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, United Kingdom
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed