A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-C… (NCT03688152) | Clinical Trial Compass
CompletedPhase 1
A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma
United States9 participantsStarted 2018-12-03
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior systemic treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligible for further treatment with standard of care.
* Willing to undergo pretreatment and on-treatment incisional or excisional biopsy of nontarget adenopathy or extranodal lesions. Provision of the most recent, available archived tumor biopsy may satisfy the pretreatment biopsy.
* Measurable disease as defined by the Lugano classification criteria:
* ≥ 1 measurable nodal lesion (≥ 1.5 cm in longest dimension) or ≥ 1 measurable extranodal lesion (\> 1 cm in longest dimension) on CT scan or MRI
* ≥ 1 PET-avid lesion.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Willingness to avoid pregnancy or fathering children based on protocol-defined the criteria.
Exclusion Criteria:
* Laboratory values outside the protocol-defined range at screening unless approved by the medical monitor.
* Primary mediastinal (thymic) large B-cell lymphoma or Richter's Syndrome.
* Known brain or central nervous system metastases or history of uncontrolled seizures.
* Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
* Allogeneic stem cell transplant within the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of treatment-emergent adverse events (TEAEs)