This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma (NCT03229278), a na phase 1 study. The primary outcome is Maximum Tolerated Dose (MTD))/Recommended Phase 2 Dose of Trigriluzole.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03229278 |
| Phase | Phase 1 |
| Condition | Lymphoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with metastatic or unresectable solid malignancies or lymphoma. The registry condition list includes several cancer types and stages, including melanoma, renal cell cancer, bladder cancer, lung cancer, head and neck cancer, and lymphoma. The eligibility criteria and characteristics of those enrolled are not reported in the registry record.
Intervention
The intervention combined trigriluzole with a PD-1 blocking antibody. The registry describes trigriluzole with nivolumab during dose finding, followed by testing the identified maximum tolerated dose with pembrolizumab. Listed trigriluzole schedules include dosing by mouth on specified daily schedules; the full treatment details are not reported in the registry record.
Comparator
There was no separate control group or randomized comparator: the record identifies a single-group study with allocation listed as not applicable and no masking. The dose groups are not like-for-like control groups. Their safety counts should not be read as randomized comparisons or as evidence that one regimen is safer than another.
Primary question
The primary aim was to identify the maximum tolerated dose of trigriluzole in combination with nivolumab and the recommended phase 2 dose. The record says the identified dose would then be tested with pembrolizumab using the same escalation, de-escalation, or stay rules. The dose result itself is not reported in the registry record.
3. Trial Design
This was a phase I study sponsored by Rutgers, The State University of New Jersey. The registry lists the study as completed, with a start date of 2017-10-03 and primary completion date of 2022-10-20. Enrollment is listed as 14. These details describe the registry record; enrollment is not necessarily the denominator for every endpoint or safety measure.
The design is listed as single-group, with allocation not applicable and masking absent. Its central task was dose finding rather than a randomized comparison of treatments. The registry describes trigriluzole combined with nivolumab during the dose-finding stage, with the identified maximum tolerated dose then tested in combination with pembrolizumab. The description refers to escalation, de-escalation, and stay rules but does not report the detailed decision criteria.
The record lists four nivolumab–trigriluzole groups in the adverse-event information: trigriluzole 140 mg taken by mouth daily, 140 mg twice a day, 140 mg/280 mg, and 280 mg twice a day. These labels identify reported safety groups, not randomized treatment arms. The treatment description also refers to an initial period of trigriluzole before nivolumab and gives a nivolumab schedule; the full regimen information is not reported in the registry record.
Alongside the primary dose measure, the registry lists outcomes including dose-limiting toxicities, objective response, survival, time to next therapy or death, freedom from new metastases, landmark survival, and duration of response. The record lists 11 outcome measures and 0 analyses. It does not report a primary dose estimate or results for these listed outcomes.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID |
|---|---|---|---|---|
| STARTED | 3 | 6 | 3 | 2 |
| COMPLETED | 3 | 6 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 6 | 3 | 2 | 14 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 3 | 1 | 0 | 5 |
| Age, Categorical: >=65 years | Participants | 2 | 3 | 2 | 2 | 9 |
| Sex: Female, Male: Female | Participants | 1 | 4 | 1 | 0 | 6 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 2 | 2 | 8 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 3 | 6 | 2 | 1 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD))/Recommended Phase 2 Dose of Trigriluzole, measured over Four weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose and recommended phase 2 dose of trigriluzole, measured in mg. The stated timeframe is four weeks. The registry description says the maximum tolerated dose would be identified with nivolumab and then tested with pembrolizumab using the same escalation, de-escalation, or stay rules. It also says adverse-event type, severity, and frequency would be recorded.
In general, dose-finding studies seek a dose suitable for further evaluation while monitoring toxicity. A maximum tolerated dose is a dose-selection outcome, not a measure of tumor response or survival. The recommended phase 2 dose is intended to guide later study; it is not, by itself, evidence of clinical benefit.
The registry record does not report the dose identified, the decision rules in sufficient detail to reproduce dose selection, or the adverse-event information used to determine the primary endpoint. A separate listed outcome is the number of participants who experienced dose-limiting toxicities, but no result for that measure is reported in the registry record. As a result, the primary endpoint’s planned meaning can be described, but its observed value and precision cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study’s stated purpose was dose finding for trigriluzole combined with nivolumab, followed by testing the identified dose with pembrolizumab. The registry record identifies a four-week timeframe for the primary maximum tolerated dose and recommended phase 2 dose measure. However, it does not report the dose selected or the primary endpoint result. The record therefore does not support an estimate of the dose-finding outcome or its precision.
The study is listed as single-group, without masking or an allocation process. Its reported dose groups are not randomized controls. Differences in their event counts cannot be interpreted as treatment effects because the groups do not provide a like-for-like comparison, and the record does not report the allocation process, participant characteristics by group, or adjusted analyses. Even where group counts differ, those counts alone do not show that a regimen caused more or fewer events.
The registry lists objective response rate and several time-to-event outcomes, including overall survival and time to next therapy or death. It also lists freedom from new metastases, landmark survival rates, and duration of response for responding patients. Results for these measures are not reported in the registry record. There are no posted estimates or uncertainty intervals from which to assess the magnitude or precision of any efficacy outcome. The record’s listing of an outcome indicates that it was planned or registered, not that a result is available.
Safety information is reported by the four nivolumab–trigriluzole groups, with counts for participants at risk and affected by serious and other adverse events, as well as deaths. The record also names serious adverse-event terms with percentages. These data describe reported events, but the registry information does not establish whether an event was caused by a study treatment. Group-specific counts should be read descriptively, not as comparative evidence.
Overall, the available record documents a completed phase I dose-finding study and some safety counts, but leaves the central dose result and the listed efficacy results unavailable. A completed status does not fill that reporting gap. Without the dose-selection result, the detailed analysis methods, and endpoint estimates, readers cannot evaluate how the intended dose decision was reached or how precisely clinical outcomes were estimated.
9. Statistical Methods Explained
Statistical methods matter in a dose-finding study because the main task is to choose a dose using accumulating safety information, not to estimate a treatment effect against a control group. The registry describes escalation, de-escalation, or stay rules, but the detailed rules and dose decision criteria are not reported in the registry record. No dose-selection calculation can be reconstructed from the posted results.
What does a maximum tolerated dose represent?
In general, dose-finding methods use observed toxicities to guide whether dose escalation should continue, stop, or change direction. The chosen dose depends on the study’s prespecified toxicity definitions, observation window, and decision rules. Those details are important because different rules can lead to different selections from the same observed safety experience. The registry identifies a four-week timeframe for the primary measure, but does not report the full rules or the selected dose.
The maximum tolerated dose is not automatically the dose with the best balance of all clinical outcomes. In general, a recommended phase 2 dose is a dose selected for further study, informed by tolerability and the study’s dose-finding approach. Neither term alone describes tumor response, survival, or comparative benefit. The registry does not report the basis for its recommended phase 2 dose.
Why is there no treatment-effect comparison?
The study is identified as single-group, with allocation listed as not applicable and masking absent. In general, a randomized control group can help distinguish a treatment effect from differences in participant characteristics, changes over time, or other influences. This record does not describe such a comparator. Its dose groups are not randomized controls, so comparing their event counts would not yield a valid causal estimate of one regimen versus another.
Unmasked assessment can also matter when outcomes involve judgment, such as response assessments or decisions about subsequent therapy. The registry lists objective response assessed according to Response Evaluation Criteria in Solid Tumors Version 1.1, but does not report the assessment procedures, whether review was independent, or the result. This means the record does not allow readers to evaluate how assessment might have influenced the outcome.
How should estimates and uncertainty be read?
In general, an estimate describes the observed value of an outcome, while a confidence interval describes the range of values compatible with the data under the method used. Wider intervals indicate less precision. For a dose-finding endpoint, the uncertainty also depends on the number of participants observed at each dose and the dose-selection rules. The registry record does not provide a primary dose estimate, confidence interval, or sufficient dose-specific endpoint information to assess precision.
For binary outcomes such as objective response, a proportion is commonly reported with an uncertainty interval. For time-to-event outcomes such as overall survival, methods account for the timing of events and follow-up, and may also account for participants whose event status is not yet known. These are general statistical approaches, not methods confirmed for this study. The registry does not report the analysis methods, estimates, uncertainty intervals, or follow-up information for the listed efficacy outcomes.
For count outcomes, variability can exceed what a simple model assumes. In general, over-dispersion means that observed counts vary more than an assumed statistical distribution allows; a model that ignores it can understate uncertainty. This concept may matter for event counts, but the registry does not report a count model or any adjusted analysis. No statistical model should be attributed to the study based on the outcome names alone.
What can the safety counts establish?
The posted safety information gives group-specific counts of participants at risk and participants affected by serious and other adverse events, together with deaths. These are descriptive summaries. A count of affected participants does not provide event timing, recurrence, severity grading, relationship to treatment, or a comparison adjusted for differences among groups. The record says adverse-event type, severity, and frequency would be recorded for the dose endpoint, but it does not provide those details for the reported counts.
Statistical comparisons would require a defined question, suitable comparison groups, and a prespecified method. None is reported for treatment-effect analyses: the registry lists 0 analyses. The counts should therefore be interpreted as registry-reported safety information, not as an estimate of relative risk or proof of causation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary maximum tolerated dose and recommended phase 2 dose measure, alongside secondary outcomes that include dose-limiting toxicities, objective response rate, overall survival, time to next therapy or death, freedom from new metastases, landmark survival rates, and duration of response. It lists 11 outcome measures and 0 analyses. Results for these outcomes are not reported in the registry record.
When a study assesses multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately. In general, multiplicity methods can control that risk or define which outcomes are confirmatory and which are exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether any formal hypothesis tests were planned. No significance claims can therefore be assessed from this record.
The analysis populations are not reported in the registry record. It does not state which participants were included in each endpoint analysis, how participants who stopped treatment were handled, or whether analyses followed an intention-to-treat or other defined population. Missing-data methods and the extent of missing outcome information are also not reported. For time-to-event measures, censoring rules and follow-up completeness are not reported.
These omissions affect interpretation: denominators may differ across outcomes, and missing observations can influence estimates. The listed enrollment does not establish the number analyzed for any specific endpoint. Without analysis populations, missing-data procedures, and outcome results, readers cannot determine how complete or comparable the endpoint data were.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | 3 | 3 | 100.0% |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | 4 | 6 | 66.7% |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | 0 | 3 | 0.0% |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID | 2 | 14 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | 2 of 3 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | 3 of 6 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | 2 of 3 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID | 0 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | 3 of 3 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | 6 of 6 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | 3 of 3 |
| Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID | 2 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID |
|---|---|---|---|---|---|
| Intracranial hemorrhage | Nervous system disorders | 1 of 3 | 2 of 6 | 0 of 3 | 0 of 14 |
| Flank pain | Musculoskeletal and connective tissue disorders | 0 of 3 | 2 of 6 | 0 of 3 | 0 of 14 |
| Atrial fibrillation | Cardiac disorders | 0 of 3 | 0 of 6 | 0 of 3 | 1 of 14 |
| Abdominal pain | Gastrointestinal disorders | 1 of 3 | 0 of 6 | 0 of 3 | 0 of 14 |
| Constipation | Gastrointestinal disorders | 1 of 3 | 0 of 6 | 0 of 3 | 0 of 14 |
| Esophagitis | Gastrointestinal disorders | 1 of 3 | 0 of 6 | 0 of 3 | 0 of 14 |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 6 | 0 of 3 | 1 of 14 |
| Thromboembolic event | Vascular disorders | 1 of 3 | 0 of 6 | 0 of 3 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg | Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID |
|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 2 of 6 | 2 of 3 | 2 of 14 |
| Lipase increased | Investigations | 1 of 3 | 4 of 6 | 1 of 3 | 1 of 14 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 3 | 1 of 6 | 1 of 3 | 2 of 14 |
| Diarrhea | Gastrointestinal disorders | 0 of 3 | 2 of 6 | 2 of 3 | 1 of 14 |
| Aspartate aminotransferase increased | Investigations | 1 of 3 | 1 of 6 | 1 of 3 | 2 of 14 |
| Lymphocyte count decreased | Investigations | 1 of 3 | 2 of 6 | 2 of 3 | 0 of 14 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 3 | 1 of 6 | 2 of 3 | 0 of 14 |
| Anemia | Blood and lymphatic system disorders | 1 of 3 | 1 of 6 | 2 of 3 | 1 of 14 |
| Alanine aminotransferase increased | Investigations | 1 of 3 | 1 of 6 | 1 of 3 | 1 of 14 |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | 1 of 3 | 1 of 6 | 0 of 3 | 2 of 14 |
Serious events with the highest arm-level rate: abdominal pain (33.3%), constipation (33.3%), esophagitis (33.3%), flank pain (33.3%), intracranial hemorrhage (33.3%).
The registry reports serious and other adverse-event counts for four nivolumab–trigriluzole groups. For trigriluzole 140 mg by mouth daily, 3 participants were at risk and 3 were affected by serious events; 3 were at risk and 3 were affected by other events; deaths were 2. For trigriluzole 140 mg twice a day, the corresponding counts were 6 and 4 for serious events, 6 and 6 for other events, and 3 deaths.
For the 140 mg/280 mg group, the counts were 3 at risk and 0 affected by serious events, 3 at risk and 3 affected by other events, and 2 deaths. For trigriluzole 280 mg twice a day, the counts were 14 at risk and 2 affected by serious events, 14 at risk and 2 affected by other events, and 0 deaths. These are group-specific registry counts, not randomized comparisons.
The registry lists abdominal pain, constipation, esophagitis, flank pain, intracranial hemorrhage, and thromboembolic event among serious adverse-event terms, each at 33.3%. The term-specific denominator is not reported in the registry record. The counts and terms do not establish causation, and the record does not give enough detail to assess timing, recurrence, severity by event, or attribution. Death counts should not be interpreted as treatment-related deaths because cause and attribution are not reported.
12. What the Result Does, and Does Not, Mean
The record describes a phase I study designed to identify a tolerable dose of trigriluzole with nivolumab and then test that dose with pembrolizumab. It reports the primary endpoint’s intended measure and timeframe, as well as group-specific safety counts. It does not report the selected dose or the result for the primary endpoint.
The distinction between a study objective and a study result is important. A registered aim to identify a maximum tolerated dose does not show which dose was selected, how the dose decision was made, or whether the recommended phase 2 dose was supported by the observed safety data. Similarly, registered efficacy outcomes are not evidence of efficacy unless their observed results and uncertainty are reported. Objective response and survival results are not reported in the registry record.
The safety counts are useful as descriptions of what the registry reports for the listed groups. They do not establish that the study treatments caused the events or deaths. Nor do the groups serve as a valid comparative basis for deciding that one trigriluzole schedule is safer than another. The study’s single-group design and lack of randomization limit causal comparisons.
These limitations do not mean that no results exist outside the registry record; they mean that conclusions about those results cannot be drawn from the record as posted. Without endpoint estimates, uncertainty measures, analysis populations, and detailed methods, the magnitude and precision of the study’s dose and clinical outcome findings cannot be assessed. The most defensible interpretation is therefore focused on the study’s design and the descriptive safety information, rather than on claims about treatment effect.
13. Why This Trial Matters Statistically
This trial illustrates the role of phase I research in characterizing dose and safety before later-stage evaluation. Its primary endpoint is a dose-selection outcome, rather than a direct comparison of treatment benefit. That distinction helps readers avoid treating a maximum tolerated dose or recommended phase 2 dose as proof of efficacy.
The single-group design also clarifies what the posted safety information can and cannot answer. Counts by dose group can describe reported events, but without random allocation they do not isolate the effect of one schedule from differences in the people receiving it or other aspects of treatment. Careful interpretation is especially important when group sizes and event counts are limited, though the record does not give enough information to quantify precision for the primary endpoint.
Another statistical lesson is the importance of complete reporting. The registry identifies a primary measure and a range of secondary outcomes, but lists 0 analyses and does not report the dose result or efficacy estimates. Stating outcome definitions, analysis populations, missing-data handling, and uncertainty would make it possible to understand how evidence was generated and how much weight to place on it.
The study’s stated sequence—dose finding with nivolumab followed by testing the identified dose with pembrolizumab—also makes the treatment context important. The safety findings are tied to the regimens named in the record; they should not be generalized to other schedules or populations. Statistical interpretation depends not only on the outcome labels but on the design, denominator, and method used to reach each result.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves important trial details unavailable for statistical interpretation. It does not report eligibility criteria, baseline characteristics, participant flow, dose-specific enrollment for the primary endpoint, or the analysis population. Although enrollment is listed as 14, this does not establish the denominator for each outcome or safety summary.
The detailed dose-escalation rules, toxicity definitions, and rationale for selecting a recommended phase 2 dose are not reported in the registry record. The full treatment description is also incomplete, including details of how the pembrolizumab stage was conducted. Without these details, the dose-finding process cannot be independently reconstructed.
Most importantly, the primary dose result and the listed efficacy outcome results are not reported. The registry also does not report confidence intervals, analysis methods, follow-up completeness, missing-data procedures, or outcome-specific denominators. The record lists serious and other adverse-event counts, but does not report event attribution, timing, recurrence, or the cause of deaths.
The study was not randomized and had no masking. Its groups are not control groups, so descriptive differences between their reported counts cannot establish comparative safety or efficacy. These limitations apply to interpretation of the registry record and do not establish what may be available elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma — NCT03229278.
- Registry record last updated 2023-12-06; status last verified 2023-11.
- Results first posted 2023-12-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03229278 is a completed phase I, single-group study sponsored by Rutgers, The State University of New Jersey. It evaluated trigriluzole in combination with nivolumab, with the stated plan to test the identified maximum tolerated dose with pembrolizumab. The registry lists enrollment as 14 and identifies metastatic or unresectable solid malignancies or lymphoma as the study population.
The primary endpoint was the maximum tolerated dose and recommended phase 2 dose of trigriluzole, measured in mg over four weeks. The registry lists 11 outcome measures and 0 analyses. It reports adverse-event counts for four nivolumab–trigriluzole groups, but does not report the primary dose result, efficacy estimates, analysis populations, or methods for handling missing data. The listed group counts are descriptive and do not form a randomized comparison.