A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)
- Conditions
- Squamous Carcinoma of the Anal CanalMedDRA version: 20.0Level: LLTClassification code 10002127Term: Anal canal cancer recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002070-51-GB
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 81
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 < 6 months from completion of treatment.
5. Must have measurable disease by RECIST v1.1.
6. ECOG performance status 0 to 1.
7. If a participant is known to be HIV-positive, then all of the following criteria must also be met:
a. CD4+ count = 300/µL.
b. Undetectable viral load.
c. Receiving highly active antiretroviral therapy (ART).
8. Willingness to avoid pregnancy or fathering children based on the criteria below.
a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 6 months after the last dose of study drug (or longer as appropriate based on country-specific requirements) and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
b. Women of childbearing potential must have a negative serum pregnancy test at screening and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 6 months after the last dose of study drug. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
c. Women of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR = 12 months of amenorrhea and at least 50 years of age) are eligible.
9. Participants known to be HIV-positive are eligible to enter the translational substudy, which requires the participant to sign a separate ICF, and the participant must be willing and able to provide additional tissue and blood samples.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51
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.
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).
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 study drug.
17. Has received a live vaccine within 28 days of the planned start of study drug.
Note: Examp
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>progressed after platinum-based chemotherapy.;Secondary Objective: To determine additional measures of clinical benefit, specifically, DOR, DCR, PFS, and OS.<br><br>To evaluate the safety of INCMGA00012 in participants with previously treated SCAC.<br><br>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 Outcome Measures
Name Time Method 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<br>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<br>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<br>therapy until death due to any cause.<br><br>Safety, determined by the number of participants; the frequency, duration, and severity of AEs; laboratory tests; vital signs; and ECGs.<br><br>Population PK, including Cmax, Tmax, Cmin, and AUC0-t, will be summarized.;Timepoint(s) of evaluation of this end point: Through out study