Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)
Public ClinicalTrials.gov record NCT04456699. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.
Study identification
- NCT ID
- NCT04456699
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 335 participants
Conditions and interventions
Conditions
Interventions
- Olaparib Drug
- 5-FU Drug
- Bevacizumab Drug
- Capecitabine Drug
- Leucovorin/ levoleucovorin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 19, 2020 (Actual)
- Primary completion
- Mar 27, 2023 (Actual)
- Completion
- Nov 6, 2023 (Actual)
- Last update posted
- Oct 29, 2024
2020 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392) | Burbank | California | 91505 | — |
| St Joseph Heritage Healthcare-Oncology ( Site 1383) | Fullerton | California | 92835 | — |
| UC Health Memorial Hospital ( Site 1401) | Colorado Springs | Colorado | 80909 | — |
| Poudre Valley Health System ( Site 1402) | Fort Collins | Colorado | 80528 | — |
| University Cancer & Blood Center, LLC ( Site 1381) | Athens | Georgia | 30607 | — |
| University of Chicago ( Site 1357) | Chicago | Illinois | 60637 | — |
| Illinois Cancer Care, PC ( Site 1352) | Peoria | Illinois | 61615 | — |
| James Graham Brown Cancer Center ( Site 1393) | Louisville | Kentucky | 40202 | — |
| University Medical Center New Orleans ( Site 1365) | New Orleans | Louisiana | 70112 | — |
| New England Cancer Specialists ( Site 1422) | Scarborough | Maine | 04074 | — |
| Cancer & Hematology Centers of Western Michigan ( Site 1358) | Grand Rapids | Michigan | 49503 | — |
| Hattiesburg Clinic Hematology/Oncology ( Site 1418) | Hattiesburg | Mississippi | 39401 | — |
| Washington University in St. Louis ( Site 1384) | St Louis | Missouri | 63110 | — |
| St. Vincent Frontier Cancer Center-Research ( Site 1414) | Billings | Montana | 59102 | — |
| CHI Health St. Francis ( Site 1406) | Grand Island | Nebraska | 68803 | — |
| Cancer Partners of Nebraska ( Site 1353) | Lincoln | Nebraska | 68510 | — |
| Providence Portland Medical Center ( Site 1400) | Portland | Oregon | 97213 | — |
| Oregon Health & Science University ( Site 1411) | Portland | Oregon | 97232 | — |
| Allegheny Singer Research Institute ( Site 1364) | Pittsburgh | Pennsylvania | 15212 | — |
| West Cancer Center - East Campus ( Site 1396) | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center ( Site 1362) | Nashville | Tennessee | 37232 | — |
| Baylor Scott & White Medical Center - Temple ( Site 1397) | Temple | Texas | 76508 | — |
| Blue Ridge Cancer Care ( Site 1374) | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04456699, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2024 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04456699 live on ClinicalTrials.gov.