Study of M3814 in Combination With Capecitabine and Radiotherapy in Rectal Cancer
- Participants who have an Eastern Cooperative Oncology Group Performance Status less than or equals to (≤) 1
- Participants who have histologically confirmed and localized resectable rectal cancer (Stage III).
- Participants who received induction chemotherapy are allowed to be enrolled to this study except this induction is resulting in complete response.
- Participants who have lower edge of the tumor located in rectum
- Adequate hematological, hepatic and renal function as defined in the protocol
- Male participants if they agree to the following during the study intervention period and for at least 12 weeks after the last dose of study intervention
- Female participants are eligible if not pregnant or breastfeeding
- Other protocol defined inclusion criteria could apply
- Participants with history of any other significant medical disease or psychiatric conditions that might in the assessment of the Investigator preclude safe participation in the study
- Participants with history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study intervention
- Unstable cardiovascular function within 6 months prior to enrollment
- Hypertension uncontrolled by medication (ie, systolic blood pressure >= 150 millimeter of mercury (mmHg) and diastolic blood pressure >= 90 mmHg)
- Participants with history of other malignant disease within the past 5 years, other than successfully treated basal carcinoma of the skin or carcinoma in situ of the cervix
- Participants with known human immunodeficiency virus positivity, known active hepatitis (for example, hepatitis B virus or hepatitis C virus), current alcohol abuse, or cirrhosis
- Participants with ongoing active infection other than human immunodeficiency virus, hepatitis B virus, or hepatitis C virus, or treatment with a live attenuated vaccine within 4 weeks of dosing
- Participants with concomitant use of H2-blocker or proton pump inhibitors (PPIs) (or unable to stop at least 5 days prior to the first treatment). Note that calcium carbonate is acceptable
- Participation in any interventional clinical study within 28 days prior to Screening or during participation in this study
- Other protocol defined exclusion criteria could apply.
Trial Phase Phase I/II
Trial Type Treatment
EMD Serono Research & Development Institute, Inc.
- Primary ID MS100036_0020
- Secondary IDs NCI-2019-00434, 2018-002275-18
- Clinicaltrials.gov ID NCT03770689