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Clinical Trials in Germany / NCT02912559
Active, not recruiting Phase 3

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

NCT02912559 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2017-10-16
Last updated
2026-08-04

Condition(s) studied

Colon AdenocarcinomaDNA Repair DisorderLynch SyndromeStage III Colon Cancer AJCC v8

Investigational drug(s) / intervention(s)

Atezolizumab →Biospecimen CollectionComputed TomographyFluorouracil →Leucovorin Calcium →Magnetic Resonance ImagingOxaliplatin →Quality-of-Life Assessment

Atezolizumab: Given IV

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Magnetic Resonance Imaging: Undergo MRI

Oxaliplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Study summary

This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with dMMR colon cancer.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically proven stage III colon adenocarcinoma (any T \[Tx, T1, T2, T3, or T4\], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve) * Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status * Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by PCR-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins) * Patients who are known to have Lynch syndrome, have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2), and have been shown to be dMMR by IHC are eligible to participate * Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margins are acceptable so long as en bloc resection was performed; proximal or distal margin positivity is not permitted * Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary; patients with more than one primary colon adenocarcinoma are eligible if the qualifying stage III tumor is confined to the colon, and not rectum, and the other cancers of lower stage are removed in the en bloc R0 resection * Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (included with distal), and further categorization will be as follows: cecum/ascending, transverse, descending, sigmoid colon, or rectosigmoid colon * No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible * No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6 * Age \>= 12 years * Performance Status: * Patients \< 16 years of age: Lansky \>= 50% * Patients 16 to \< 18 years of age: Karnofsky \>= 50% * Patients \>= 18 years of age: Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * This study involves: 1) an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; and 2) an agent that has known genotoxic, mutagenic, and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months) * Absolute neutrophil count (ANC) \>= 1500 mm\^3 * Platelet count \>= 100,000 mm\^3; platelets \>= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration * Creatinine =\< 1.5 x upper limit of normal (ULN) or * Calculated creatinine clearance \>= 45 mL/min by Cockcroft-Gault equation * Alternatively, for patients \< 18 years of age, maximum serum creatinine =\< the below age-gender-specific norms: * 12 years: 1.2 (male and female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * 16 to \< 18 years: 1.7 (male), 1.4 (female) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible * No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency * No known active hepatitis B or C * Active hepatitis B can be defined as: * Hepatitis B virus surface antigen (HBsAg) detectable for \> 6 months; * Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B * Persistent or intermittent elevation in ALT/AST levels * Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation * Active hepatitis C can be defined as: * Hepatitis C antibody (AB) positive AND * Presence of hepatitis C virus (HCV) RNA * Excluded if known active pulmonary disease with hypoxia defined as: * Oxygen saturation \< 85% on room air, or * Oxygen saturation \< 88% despite supplemental oxygen * No grade \>= 2 peripheral motor or sensory neuropathy * Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following: * A stable regimen of highly active anti-retroviral therapy (HAART) * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections * A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests * No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study * No systemic daily treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration * No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins * No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation * No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

Primary outcome measure(s)

Trial sites (1049)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Cancer Center at Saint Joseph's Phoenix Arizona
Mayo Clinic Hospital in Arizona Phoenix Arizona
Mayo Clinic in Arizona Scottsdale Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
Kaiser Permanente-Anaheim Anaheim California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mills-Peninsula Medical Center Burlingame California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
Eden Hospital Medical Center Castro Valley California
Community Cancer Institute Clovis California
University Oncology Associates Clovis California
John Muir Medical Center-Concord Concord California
UC Irvine Health Cancer Center-Newport Costa Mesa California
Sutter Davis Hospital Davis California
Epic Care-Dublin Dublin California
Epic Care Partners in Cancer Care Emeryville California
Kaiser Permanente-Fontana Fontana California
Palo Alto Medical Foundation-Fremont Fremont California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
Keck Medicine of USC Koreatown Los Angeles California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Los Angeles General Medical Center Los Angeles California

+ 1009 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02912559 on ClinicalTrials.gov ↗ ← All trials in Germany