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| ID | Type | Description | Link |
|---|---|---|---|
| 20-C-0138 |
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Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers cannot be cured and are often not helped by standard treatments. Researchers want to find better treatments by testing a combination of drugs.
Objective:
To learn if a new combination of immunotherapy drugs can shrink tumors in people with advanced small bowel and colorectal cancers.
Eligibility:
People ages 18 and older who have advanced metastatic or refractory/recurrent small bowel and/or colorectal cancer.
Design:
Participants will be screened on a separate protocol. They will have a physical exam and medical history. They will have imaging scans. They will have blood and urine tests. Their heart function will be measured. They may have a tumor biopsy.
Participants will repeat some of the screening tests during the study.
Participants will be put into study groups. Each group will get a combination of the following drugs: CV301 vaccine (modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301), M7824 (MSB0011359C), and N-803 (Anktiva). Some will also get NHS-IL12 (M9241).
Participants will get the CV301 vaccines by injection under the skin. They will get M7824 by intravenous infusion every 2 weeks. They will get N-803 by injection under the skin every 2 or 4 weeks. They may get NHS-IL12 by injection under the skin every 4 weeks. They will take the study drugs for up to 1 year. They will visit the National Institutes of Health (NIH) every 2 weeks.
After treatment ends, participants will go to the clinic for a 28-day follow-up visit or have a telephone call. They will be contacted every 3 months for 1 year, and then every 6 months after that for the rest of their life.
Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers are incurable and poorly palliated by standard therapies. There is an unmet need for active treatments for these tumors.
To date immunotherapies including anti programmed cell death protein 1 (PD-1) or anti programmed death-ligand 1 (PD-L1) inhibitors have proven largely ineffective for the vast majority of these cancers.
Objectives:
To evaluate the objective response rate (ORR) according to Response Evaluation Criteria (Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) of the combination of (1) CV301, a poxviral based vaccine targeting carcinoembryonic antigen (CEA) and mucin-1 (MUC1), (2) N-803 and (3) M7824; and of the combination of (1) CV301, (2) N-803, (3) M7824 and (4) NHS-IL12 (M9241) in subjects with advanced checkpoint naive microsatellite stable (MSS) small bowel and colorectal cancers.
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Arm 1 | Experimental | CEA/ MUC1 Vaccines + M7824 + N-803 (Triple Therapy). |
|
| 2/Arm 2A | Experimental | CEA/ MUC1 Vaccines + M7824 + N-803 + NHSIL12 (Quadruple Therapy); dose escalation of NHS-IL12. |
|
| 3/Arm 2B | Experimental | CEA/ MUC1 Vaccines + M7824 + N-803 + NHSIL12 (Quadruple Therapy); fixed dose of NHS-IL12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CV301 | Biological | CV301 vaccine consists of MVA-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous injections on D1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) for Triple Therapy | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | one year |
| Objective Response Rate (ORR) for Quadruple Therapy | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Safety of the combination of (1) CV301, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
-INCLUSION CRITERIA:
Subjects with cytologically or histologically confirmed locally advanced or metastatic small bowel or colorectal adenocarcinoma
Subjects must have received two prior lines of systemic therapy unless the subject is not eligible to receive standard therapy or declines standard treatment
Subjects must have measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Adequate hematologic function at screening, as follows:
Adequate renal and hepatic function at screening, as follows:
- Serum creatinine <= 1.5 x upper limit of normal (ULN) OR
Measured or calculated creatinine clearance >= 40 mL/min for participant with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl);
The effects of the immunotherapies on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment and up to two months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Participants serologically positive for human immunodeficiency virus (HIV), Hep B, Hep C are eligible as long as the viral loads are undetectable by quantitative polymerase chain reaction (PCR). HIV positive participants must have cluster of differentiation 4 (CD4) count >= 200 cells per cubic millimeter at enrollment, be on stable antiretroviral therapy for at least 4 weeks and have no reported opportunistic infections or Castleman s disease within 12 months prior to enrollment.
Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
Participants with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to the first drug administration except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the participant is otherwise suitable for enrollment. Additionally, current therapies (e.g., maintenance capecitabine) may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression. Also, participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast).
Participants with microsatellite unstable or mismatch repair deficient disease.
Major surgery within 28 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted).
Known life-threatening side effects resulting from prior checkpoint inhibitor therapy (e.g., colitis, pneumonitis, fulminant hepatitis which led to permanent discontinuation of prior checkpoint therapy). Autoimmune toxicity which was not life threatening (e.g., arthritis) or did not lead to discontinuation of prior checkpoint therapy is allowed.
Known active brain or central nervous system metastasis (less than a month out from definitive radiotherapy or surgery), seizures requiring anticonvulsant treatment (<3 months) or clinically significant cerebrovascular accident (<3 months). In order to be eligible participants must have repeat central nervous system (CNS) imaging at least a month after definitive treatment showing stable CNS disease. Participants with evidence of intra-tumoral or peritumoral hemorrhage on baseline imaging are also excluded unless the hemorrhage is grade <= 1 and has been shown to be stable on two consecutive imaging scans.
Pregnant women are excluded from this study because these drugs have not been tested in pregnant women and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these immunotherapies, breastfeeding should be discontinued if the mother is treated on this protocol.
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent with exception of:
Subjects with a history of serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, bleeding diathesis or recent (within 3 months) clinically significant bleeding events or other illness considered by the Investigator as high risk for investigational drug treatment.
Subjects unwilling to accept blood products as medically indicated.
History of second malignancy within 3 years of enrollment except for the following: adequately treated localized skin cancer, cervical carcinoma in situ, superficial bladder cancer, or other localized malignancy which has been adequately treated or malignancy which does not require active systemic treatment (e.g., low risk chronic lymphocytic leukemia (CLL).
Subjects with a known severe hypersensitivity reaction to a monoclonal antibody (grade >= 3 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE v5) will be evaluated by the allergy/immunology team prior to enrollment.
Receipt of any organ transplantation requiring ongoing immunosuppression.
Receipt of prior lymphodepleting chemotherapy (e.g., cyclophosphamide or fludarabine at standard lymphodepleting doses).
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| Name | Affiliation | Role |
|---|---|---|
| Hoyoung Maeng, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41520164 | Derived | Bracken-Clarke D, Pastor DM, Marte JL, Donahue RN, Hodge JW, Cordes L, Floudas CS, Tschernia NP, Karzai F, Brownell I, Turkbey EB, Soon-Shiong P, Schlom J, Gulley JL, Maeng HM, Strauss J, Redman JM. The quadruple immunotherapy for colorectal cancer (QuICC) trial for mismatch repair-proficient metastatic colorectal cancer. Oncologist. 2026 Feb 5;31(3):oyag008. doi: 10.1093/oncolo/oyag008. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the Database of Genotypes and Phenotypes (dbGaP).
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the Database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy). CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. |
| FG001 | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| FG002 | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| FG003 | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy). CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) for Triple Therapy | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Posted | Number | Proportion of participants | one year |
|
Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1; 27 months for Cohort 2, Arm 2a Dose Level (DL) 1; 18 months and 29 days for cohort 2, Arm 2a DL 2; and 7 months and 20 days for Cohort 2, Arm 2b, DL 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy). CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hoyoung Maeng | National Cancer Institute | 240-781-3253 | hoyoung.maeng@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2025 | Apr 7, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2021 | Aug 15, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C582303 | ALT-803 |
| C000594734 | NHS-IL12 immunocytokine |
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| MSB0011359C | Drug | Subjects will receive M7824 via IV infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. |
|
| N-803 | Drug | N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. |
|
| NHS-IL12 | Drug | NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
|
| Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1. |
| Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy | Safety of the combination of (1) CV301, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Date treatment consent signed to date off study, approximately 27 months for Cohort 2, Arm 2a Dose Level 1; 18 months and 29 days for cohort 2, Arm 2a Dose Level 2; and 7 months and 20 days for Cohort 2, Arm 2b, Dose Level 2. |
| Progression Free Survival (PFS) | PFS per treatment assignment (three or four drug combination was evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | From time to enrollment up to 35 months |
| Overall Survival (OS) | OS per treatment assignment (three or four drug combination) evaluated using Kaplan-Meier methods. OS is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive. | Up to 35 months |
| Duration of Response (DOR) | DOR per treatment assignment (three or four drug combination) is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Up to 34 months |
| Number of Participants Hospitalized Due to Serious Adverse Events Attributed to Progressive Disease (PD) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. And progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | time participant is first enrolled to time participant is taken off of study treatment, an average of 2.1 months. |
| Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1; 27 months for Cohort 2, Arm 2a Dose Level (DL) 1; 18 months and 29 days for cohort 2, Arm 2a DL 2; and 7 months and 20 days for Cohort 2, Arm 2b, DL 2. |
| BG001 | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| BG002 | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| BG003 | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Objective Response Rate (ORR) for Quadruple Therapy | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Posted | Number | Percentage of participants | one year |
|
|
|
| Secondary | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Safety of the combination of (1) CV301, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1. |
|
|
|
| Secondary | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy | Safety of the combination of (1) CV301, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 27 months for Cohort 2, Arm 2a Dose Level 1; 18 months and 29 days for cohort 2, Arm 2a Dose Level 2; and 7 months and 20 days for Cohort 2, Arm 2b, Dose Level 2. |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS per treatment assignment (three or four drug combination was evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Posted | Median | 95% Confidence Interval | Months | From time to enrollment up to 35 months |
|
|
|
| Secondary | Overall Survival (OS) | OS per treatment assignment (three or four drug combination) evaluated using Kaplan-Meier methods. OS is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive. | Posted | Median | 95% Confidence Interval | Months | Up to 35 months |
|
|
|
| Secondary | Duration of Response (DOR) | DOR per treatment assignment (three or four drug combination) is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 1/32 participants were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | Up to 34 months |
|
|
|
| Secondary | Number of Participants Hospitalized Due to Serious Adverse Events Attributed to Progressive Disease (PD) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. And progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Posted | Count of Participants | Participants | time participant is first enrolled to time participant is taken off of study treatment, an average of 2.1 months. |
|
|
|
| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1; 27 months for Cohort 2, Arm 2a Dose Level (DL) 1; 18 months and 29 days for cohort 2, Arm 2a DL 2; and 7 months and 20 days for Cohort 2, Arm 2b, DL 2. |
|
|
|
| 9 |
| 12 |
| 2 |
| 12 |
| 12 |
| 12 |
| EG001 | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. | 5 | 8 | 4 | 8 | 8 | 8 |
| EG002 | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. | 4 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B. | 3 | 6 | 0 | 6 | 6 | 6 |
| Adrenal insufficiency | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Duodenal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, Lower Gastrointestinal Hemorrhage |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Eye disorders - Other, conjunctival hemorrhage | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, Epistaxis, nose bleeding | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, MUCOSAL BLEEDING | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, epistaxis - intermittent |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, oral hemorrhage - intermittent when brushing teeth; expected |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, oral hemorrhage; mild bleeding when brushing teeth |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, epistaxis intermittent - blood tinge when blowing nose |
|
| General disorders and administration site conditions - Other, Mucosal bleeding | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, hemorrhoidal hemorrhage |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, nasopharyneal/post-nasal hemorrhage |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, oral hemorrhage - mild bleeding when brushing teeth |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding, oral hemorrhage intermittent when brushing teeth |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Mucosal bleeding intermittent when blows nose |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Other: mucosal bleeding, expected; epistaxis, intermittent, mild |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | Vaccination site lymphadenopathy, left groin lump |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment | mucosal bleeding, oral hemorrhage: mild bleeding when brushing teeth |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, Left 2nd toe wound | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Papulopustular rash | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, KERATOSIS PILARIS, bilateral arms | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Disease progression | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Grade 3 Cardiac troponin I increased |
|
| Grade 4 |
|
| Grade 5 |
|
|
| Grade 3 Adrenal insufficiency |
|
| Grade 3 General disorders & administration site conditions - Mucosal bleeding, lower GI hemorrhage |
|
| Grade 4 |
|
| Grade 5 |
|