Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Jun 2, 2024
  • participants needed
    44
  • sponsor
    Ali Shamseddine
Updated on 23 January 2021
Investigator
Ali I Shamseddine, M.D.
Primary Contact
H tel Dieu de France (0.0 mi away) Contact
+3 other location

Summary

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

Description

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

COMPOUND 2055269 has demonstrated meaningful clinical activity across various tumor types and treatment settings. No clinical trial is conducted over COMPOUND 2055269 in locally-advanced rectal adenocarcinoma.

Details
Condition Locally Advanced Rectal Cancer
Treatment radiation therapy, Total Mesorectal Excision, COMPOUND 2055269, mFOLFOX
Clinical Study IdentifierNCT03503630
SponsorAli Shamseddine
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18 years
Locally-advanced rectal cancer (cT2 N1-3, cT3 N0-3, evidence of extramural vascular or mesorectal fascia involvement)
<12 cm from anal verge
Histologically proven rectal adenocarcinoma
ECOG performance score 1
Have adequate organ function by meeting the following
Absolute neutrophil count (ANC) 1.5 109/L
Platelet count 100 109/L
Hemoglobin 9 g/dL
Total bilirubin level 1.5 the upper limit of normal (ULN) range
AST and ALT levels 2.5 ULN or AST and ALT levels 5 x ULN (for subjects with documented metastatic disease to the liver)
Estimated creatinine clearance 30 mL/min according to the Cockcroft- Gault formula (or local institutional standard method)
Negative serum or urine pregnancy test at screening for women of childbearing potential
Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last COMPOUND 2055269 treatment administration if the risk of conception exists

Exclusion Criteria

Distant metastasis (M1)
Patients with T2 N0 or T4
Recurrent rectal cancer
Symptoms or history of peripheral neuropathy
Prior radiotherapy or chemotherapy
Current use of immunosuppressive medication, except for the following
Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection)
Systemic corticosteroids at physiologic doses 10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible
Vaccination within 4 weeks of the first dose of COMPOUND 2055269 and while on trials is prohibited except for administration of inactivated vaccines
Active infection requiring systemic therapy
Known history of testing positive for the human immunodeficiency virus or known acquired immunodeficiency syndrome
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade 3)
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure ( New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade 2, or other Grade 2 not constituting a safety risk based on investigator's judgment are acceptable
Prior organ transplantation including allogenic stem-cell transplantation
Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Concurrent treatment with a non-permitted drug
Patients suspected by the physician that he/she will not compliant to the protocol conduct
Pregnant or breastfeeding patients
Patient participating in another clinical trial
Patient who is not willing to sign the consent form
Any psychiatric condition that would prohibit the understanding or rendering of informed consent
Legal incapacity or limited legal capacity patients receiving other oncology specific medication not authorized in the protocol
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