18 and older, any sex, with Advanced Solid Neoplasm or Aggressive Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD)Primary· First Cycle of Treatment with velaparib and nivolumab (28 days)
The MTD will be defined as the highest dose that causes dose-limiting toxicities (DLTs) in \<2 of 6 patients. Toxicity will be assessed using CTCAEv4.03. A DLT is defined as an Adverse Event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days (1 cycle) following the first dose of veliparib and nivolumab and meets any of the following criteria:
Grade ≥ 3 non-hematologic toxicities that represent at least a 2-grade increase from baseline excluding Nausea, vomiting, diarrhea lasting ≤48 hours, Electrolyte abnormalities resolving withi
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Phase 1)
400
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5Secondary· Up to 30 days after treatment discontinuation, where 1 cycle =28 days, and range of cycles is 1-12.
Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical st
ORR (Overall Response Rate)Secondary· after 2 cycles at first response time point (1 cycle = 28 days)
Overall response rate or ORR, (partial response (PR) + complete response (CR)) will be evaluated using RECIST criteria v1.1 or Lugano 2014 classification for assessment of Lymphoma.
Per RECIST v. 1.1: PR= : At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR= Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Per Lugano 2014 classification, scored on a Deauville 5-point scale (an internationally-recommended scale using FDG PET-CT in th
Complete Response
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
0
Velaparib PO Twice Daily + Nivolumab (Phase 2)
0
Partial Response
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
0
Velaparib PO Twice Daily + Nivolumab (Phase 2)
0
Clinical Benefit Rate (CBR)Secondary· From the start of treatment and every 2 cycles during treatment where 1 cycle =28 days, average number of cycles is 4 and range of cycles is 1-12.
CBR= stable disease for ≥12 weeks + Partial Response + Complete Response per RECIST v1.1 for solid tumors or Lugano 2014 classification for lymphomas. Lugano scored on a Deauville 5-point scale. RECIST v. 1.1: PR= : At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the small
Complete Response
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
0
Velaparib PO Twice Daily + Nivolumab (Phase 2)
0
Partial Response
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
0
Velaparib PO Twice Daily + Nivolumab (Phase 2)
0
Stable Disease for or ≥12 weeks
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
4
Velaparib PO Twice Daily + Nivolumab (Phase 2)
2
Progression Free Survival (PFS)Secondary· From the start of treatment and every 2 cycles during treatment, and up to three years, where 1 cycle =28 days, and range of cycles is 1-12.
To evaluate Progression Free Survival (PFS) for patients treated with nivolumab and veliparib, defined as the time from treatment initiation to documented disease progression. Evaluated by RECIST criteria v1.1 for solid tumors or Lugano 2014 classification for assessment of Lymphoma. RECIST v. 1.1 definition for PD (Progressive disease): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Lugano 2014 classification, scored on a Deauville 5-point scale (an internationally-recommended scale using FDG PET-CT in the initial staging
Number of Patients Alive and Progression Free at 24 WeeksSecondary· At 24 weeks
To evaluate the number of patients alive and progression free at 24 weeks. -Per RECIST v. 1.1 (for solid tumors) progression is defined as : At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) -Lugano 2014 classification, scored on a Deauville 5-point scale (an internationall
Group
Value
95% CI
Velaparib PO Twice Daily + Nivolumab (Cohort 1)
0
Velaparib PO Twice Daily + Nivolumab (Cohort 2)
1
Velaparib PO Twice Daily + Nivolumab (Phase 2)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1:Cohort-1 (Velaparib 200 mg PO Twice Daily + Nivolumab)
The purpose of this research study is to determine the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Veliparib is not yet approved for use in the United States, and is considered experimental. Veliparib inhibits (blocks) the activity of the enzyme PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Nivolumab increases T cells in your immune system, which allows your immune system to attack the cancer. We think the combination of these drugs will be more effective against your cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 12 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03061188.