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 High-Risk Skin Cancers With Atezolizumab Plus NT-I7 (NCT03901573), a non-randomized phase 1, phase 2 study. The primary outcome is Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03901573 |
| Phase | Phase 1, Phase 2 |
| Condition | Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NeoImmuneTech |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients with high-risk melanoma, Merkel Cell Carcinoma, or cutaneous Squamous Cell Carcinoma who were anti-PD-1/PD-L1 naïve or had relapsed or refractory disease. The registry describes separate checkpoint-inhibitor-naïve cSCC and MCC patients and relapsed/refractory cSCC, MCC, and melanoma patients. The safety population is defined as patients who received at least 1 dose of the investigational regimen. The number of patients in each clinical subgroup is not reported in the registry record.
Intervention
The study evaluated NT-I7, also called rhIL-7-hyFc, in combination with atezolizumab. The stated purpose was to test whether adding NT-I7 to atezolizumab provided clinically meaningful outcomes in the specified patient groups. The registry lists both agents as drug interventions. Details such as dose schedules are not reported in the registry record.
Comparator
There was no randomized control group. The study is described as non-randomized, open-label, and parallel, with arms defined by disease and checkpoint-inhibitor history. The registry does not establish a like-for-like comparison between these groups, and any differences between their observed outcomes could reflect differences in who entered each group as well as treatment or dose.
Primary question
In Phase 1b, the primary question concerned the safety and tolerability of NT-I7 with atezolizumab, including estimation of the maximum tolerated dose and/or recommended Phase 2 dose. The endpoint description covers adverse events and dose-limiting toxicities. ORR is identified as a Phase 2a primary outcome measure, but a numerical ORR result is not reported in the registry record.
3. Trial Design
This was a Phase 1b/2a, open-label, non-randomized, parallel study sponsored by NeoImmuneTech. The registry lists an enrollment of 31 and the conditions melanoma, Merkel Cell Carcinoma, and cutaneous Squamous Cell Carcinoma. The study began on 2019-12-26, had a primary completion date of 2023-08-15, and is listed as terminated.
All participants were evaluated in the context of NT-I7 combined with atezolizumab; there was no randomized comparison with a control treatment. The registry describes checkpoint-inhibitor-naïve cSCC and MCC patients in one arm and relapsed/refractory cSCC, MCC, and melanoma patients in another. These clinical groups differ by both disease and prior checkpoint-inhibitor status, so they should not be treated as interchangeable groups for a causal treatment comparison. The adverse-event group listings also identify Phase 1b dose levels and a Phase 2- group, but the record does not provide enough detail to reconstruct dose assignment or relate each clinical subgroup to each listed adverse-event group.
The Phase 1b focus was safety and tolerability, including estimation of a maximum tolerated dose and/or recommended Phase 2 dose. The registry describes adverse events graded according to NCI CTCAE 5.0 and dose-limiting toxicities during the DLT window. The stated timeframe includes observation through 30 days after the last dose, approximately 25 months after enrollment, and the first 21 days from C1/D1 through Day 21. The record also identifies ORR as a Phase 2a primary outcome measure and lists secondary aims concerning immunogenicity and preliminary anti-tumor activity. Numerical efficacy results, dose schedules, and details of the design rationale are not reported in the registry record.
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 | Phase 1b-Dose Level 1 | Phase 1b-Dose Level 2 | Phase 1b-Dose Level 3 | Phase 1b-Dose Level 4 | Phase 2- |
|---|---|---|---|---|---|
| STARTED | 3 | 3 | 7 | 3 | 15 |
| COMPLETED | 2 | 2 | 4 | 3 | 7 |
| NOT COMPLETED | 1 | 1 | 3 | 0 | 8 |
Analysis population for the primary outcome, as defined in the registry: Safety: All patients who receive at least 1 dose of the investigational regimen ; DLT: All patients who receive at least 1 dose of the investigational regimen and complete the full 3-week DLT window or who do not complete the full 3-week DLT window due to the occurrence of a DLT.; Analyses of adverse events will be performed for those events that are considered treatment emergent.(Subjects with one or more AEs within a level of MedDRA are counted only once in that level)
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.
Population: The study enrolled 16 subjects in Phase 1b and 15 subjects in Phase 2a, all of whom received treatment. The Arm/Group has been combined based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W.
| Characteristic | Unit | Phase 1b | Phase 2a | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 15 | 31 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 4 | 11 |
| Age, Categorical: >=65 years | Participants | 9 | 11 | 20 |
| Age, Continuous | years | 65.4 (46 to 82) | 65.7 (39 to 82) | 65.58 (39 to 82) |
| Sex: Female, Male: Female | Participants | 7 | 6 | 13 |
| Sex: Female, Male: Male | Participants | 9 | 9 | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 15 | 13 | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): White | Participants | 11 | 12 | 23 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 2 | 4 |
| Region of Enrollment: United States | participants | 16 | 15 | 31 |
| Weight | kg | 81.42 (58.3 to 123.4) | 78.00 (54.3 to 111) | 79.71 (54.3 to 123.4) |
6. Primary Endpoint
The registry lists the primary outcome as Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose, measured over 1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The listed Phase 1b primary endpoint concerns safety and tolerability of NT-I7 in combination with atezolizumab. It is expressed as counts of participants and covers the incidence, nature, and severity of adverse events, with grading according to NCI CTCAE 5.0, as well as the incidence and nature of dose-limiting toxicities. The registry describes the safety population as patients who received at least 1 dose of the investigational regimen. For the DLT assessment, it includes patients who received at least 1 dose and completed the full 3-week DLT window, or who did not complete that window because a DLT occurred.
In an early-phase study, safety and dose-limiting toxicity information is used to characterize tolerability and inform dose selection. The stated objective includes estimating the maximum tolerated dose and/or recommended Phase 2 dose. This is a different question from whether a treatment improves a clinical outcome: counts of adverse events alone do not establish comparative benefit. The record’s description also says ORR, defined as the percentage with at least one confirmed partial or complete response according to RECIST v.1.1, is included as a Phase 2a primary outcome measure. However, a numerical ORR estimate and its precision are not reported in the registry record, so that efficacy question cannot be answered from the results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a small early-phase study with an enrollment of 31, but the posted outcome information does not include an inferential analysis of efficacy. The Phase 1b primary endpoint is safety and tolerability, not a randomized estimate of treatment benefit. Although the registry identifies ORR as a Phase 2a primary outcome measure, a numerical ORR result is not reported in the registry record. Therefore, no conclusion about the size or precision of an anti-tumor response estimate can be drawn from the posted results.
The adverse-event listings report affected-participant counts by group. For serious adverse events, Phase 1b-Dose Level 1 lists 1 affected participant among 3 at risk; Phase 1b-Dose Level 2 lists 0 among 3; Phase 1b-Dose Level 3 lists 5 among 7; Phase 1b-Dose Level 4 lists 1 among 3; and Phase 2- lists 9 among 15. These are descriptive counts within the listed groups. The corresponding counts for other adverse events are 3 among 3, 3 among 3, 7 among 7, 3 among 3, and 14 among 15, respectively. The registry also lists deaths by group, but cause, timing, and relationship to study treatment are not reported in the registry record.
These figures do not support a controlled comparison. Allocation was non-randomized, and the groups are not described as like-for-like controls. Group differences could reflect clinical composition, dose level, follow-up, or other factors that the registry does not report. Small group counts also mean that any individual participant can materially affect the descriptive count, while the record provides no confidence intervals or adjusted estimates for these outcomes.
Serious adverse-event terms appearing among the listed terms include Fatigue and Hip fracture, each reported as 33.3%; Dehydration at 28.6%; and Abdominal pain, Nausea, and Vomiting, each at 14.3%. The record does not report the term-specific denominators or detailed event narratives. These percentages should therefore be read as registry-reported summaries, not as a basis for comparing risks across treatment groups.
In general, statistical precision describes how uncertain an estimate is, often using a confidence interval. No such interval for the posted safety counts or efficacy outcome is reported in the registry record. The counts describe what was recorded in the listed groups; they do not by themselves establish causation, comparative safety, or efficacy.
9. Statistical Methods Explained
What kind of evidence does this design provide?
The study is listed as non-randomized, open-label, and parallel. In a randomized trial, random allocation is used to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. That protection is absent. Open-label means the record identifies no masking. General statistical interpretation: when treatment assignment is not randomized and participants and investigators are not masked, outcome comparisons can be influenced by differences in patient characteristics, clinical decisions, and outcome assessment. The registry does not report an adjustment method intended to address such differences.
The parallel structure means groups are followed in the same study rather than one participant being assigned to successive treatment conditions. The listed clinical arms distinguish checkpoint-inhibitor-naïve cSCC and MCC patients from relapsed/refractory cSCC, MCC, and melanoma patients. Separate adverse-event listings identify Phase 1b dose levels and a Phase 2- group. The record does not report the mapping between these descriptions, so they should not be assumed to define identical grouping schemes.
How should participant counts be read?
The Phase 1b primary endpoint is a participant count for safety events and DLTs. A count states how many participants in the defined population had an event. The adverse-event listing also gives the number at risk and the number affected for serious and other adverse events. These denominators matter: a count without its population at risk can be difficult to interpret. Even with a denominator, a descriptive count does not show whether an event was caused by treatment. The record’s DLT population has a specific rule: participants must complete the full 3-week DLT window or leave it because a DLT occurred. That rule differs from the broader safety population, defined as all patients who received at least 1 dose.
General statistical explanation: for a binary outcome such as whether a participant experienced an event, uncertainty depends on both the number of events and the number of participants observed. A confidence interval can describe a range of values compatible with the data under a statistical model. The registry record does not report confidence intervals or a model-based analysis for these adverse-event counts. It is therefore appropriate to describe the counts as observed registry summaries, without claiming a particular degree of statistical precision.
What is a dose-limiting toxicity assessment?
The stated Phase 1b objective includes estimation of the maximum tolerated dose and/or recommended Phase 2 dose. A DLT assessment focuses on predefined toxicities during a specified observation window; the registry identifies the first 21 days from C1/D1 through Day 21. General explanation: early-phase dose-finding uses safety observations to inform dose selection, but the exact decision rules depend on the protocol. Those rules, including any dose-escalation algorithm, are not reported in the registry record. The registry’s DLT count therefore cannot be used to reconstruct how a dose decision was made.
What can be inferred from ORR?
The registry describes ORR as the percentage of patients with at least one confirmed partial response or complete response according to RECIST v.1.1. This is a binary response outcome summarized as a proportion. General explanation: a response proportion can describe observed tumor responses in a treated group, while its confidence interval conveys uncertainty in that proportion. In a non-randomized single-treatment context, an observed response proportion is not by itself a causal estimate of the effect of treatment compared with an alternative. Here, no numerical ORR result or confidence interval is reported in the registry record.
What does the planning illustration assume?
The registry describes planning illustrations based on the observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The illustration uses a stated fraction of the observed effect as the effect to detect. General explanation: such calculations translate assumptions about a future comparison into a planning sample size; they are not evidence that a study had a particular probability of detecting an effect after it was conducted. The stated illustrations are not observed power. The registry does not report the trial’s own sample-size justification, and the listed non-randomized groups are not a like-for-like control comparison.
Are analysis methods fully described?
No inferential analyses are reported in the registry record. Details of statistical tests, estimators, confidence intervals, covariate adjustment, interim analyses, and missing-data handling are not reported in the registry record. Without those details and without numerical efficacy estimates, the evidence supports a limited descriptive reading of the posted safety counts rather than a reconstructed hypothesis test or treatment-effect analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcome aims: Phase 1b safety and DLT assessment, immunogenicity, preliminary anti-tumor activity, and preliminary anti-tumor activity using DCR. ORR is identified in the Phase 2a primary outcome description. When a study examines multiple outcomes or analyses, general statistical practice may address multiplicity because repeated testing can increase the chance of a seemingly notable result arising by chance. Whether the protocol specified a hierarchy, adjustment, or other multiplicity strategy is not reported in the registry record. No inferential analyses are reported in the registry record, so there is no posted testing strategy to evaluate.
Missing-data handling is also not reported in the registry record. The DLT population definition accounts for participants who do not complete the full 3-week window because a DLT occurs, but it does not describe how other incomplete observations or missing outcome assessments were handled. The record does not state whether participants were excluded from particular analyses, how outcomes after withdrawal were treated, or whether any sensitivity analyses were conducted.
The registry defines the safety population as patients who received at least 1 dose of the investigational regimen and gives a separate DLT population definition. A complete description of the analysis populations for efficacy, immunogenicity, and other outcomes is not reported in the registry record. These distinctions matter because outcome estimates depend on which participants are included and how incomplete follow-up is treated. The reported safety counts should be interpreted using their listed at-risk denominators, without assuming that the same population or follow-up applies to every outcome.
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 |
|---|---|---|---|
| Phase 1b-Dose Level 1 | 1 | 3 | 33.3% |
| Phase 1b-Dose Level 2 | 0 | 3 | 0.0% |
| Phase 1b-Dose Level 3 | 5 | 7 | 71.4% |
| Phase 1b-Dose Level 4 | 1 | 3 | 33.3% |
| Phase 2- | 9 | 15 | 60.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase 1b-Dose Level 1 | 2 of 3 |
| Phase 1b-Dose Level 2 | 3 of 3 |
| Phase 1b-Dose Level 3 | 5 of 7 |
| Phase 1b-Dose Level 4 | 1 of 3 |
| Phase 2- | 8 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Phase 1b-Dose Level 1 | 3 of 3 |
| Phase 1b-Dose Level 2 | 3 of 3 |
| Phase 1b-Dose Level 3 | 7 of 7 |
| Phase 1b-Dose Level 4 | 3 of 3 |
| Phase 2- | 14 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase 1b-Dose Level 1 | Phase 1b-Dose Level 2 | Phase 1b-Dose Level 3 | Phase 1b-Dose Level 4 | Phase 2- |
|---|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 0 of 3 | 0 of 3 | 2 of 7 | 0 of 3 | 1 of 15 |
| Acute kidney injury | Renal and urinary disorders | 0 of 3 | 0 of 3 | 1 of 7 | 0 of 3 | 2 of 15 |
| Confusional state | Psychiatric disorders | 0 of 3 | 0 of 3 | 1 of 7 | 0 of 3 | 1 of 15 |
| Anaemia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 7 | 0 of 3 | 1 of 15 |
| Adrenal insufficiency | Endocrine disorders | 0 of 3 | 0 of 3 | 0 of 7 | 0 of 3 | 1 of 15 |
| Abdominal pain | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 1 of 7 | 0 of 3 | 0 of 15 |
| Nausea | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 1 of 7 | 0 of 3 | 0 of 15 |
| Vomiting | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 1 of 7 | 0 of 3 | 0 of 15 |
| Fatigue | General disorders | 1 of 3 | 0 of 3 | 0 of 7 | 0 of 3 | 0 of 15 |
| Influenza like illness | General disorders | 0 of 3 | 0 of 3 | 0 of 7 | 0 of 3 | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase 1b-Dose Level 1 | Phase 1b-Dose Level 2 | Phase 1b-Dose Level 3 | Phase 1b-Dose Level 4 | Phase 2- |
|---|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 2 of 3 | 4 of 7 | 2 of 3 | 8 of 15 |
| Injection site reaction | General disorders | 1 of 3 | 1 of 3 | 3 of 7 | 2 of 3 | 7 of 15 |
| Pruritus | Skin and subcutaneous tissue disorders | 0 of 3 | 2 of 3 | 3 of 7 | 1 of 3 | 5 of 15 |
| Headache | Nervous system disorders | 1 of 3 | 2 of 3 | 1 of 7 | 2 of 3 | 3 of 15 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 3 | 0 of 3 | 3 of 7 | 2 of 3 | 3 of 15 |
| Decreased appetite | Metabolism and nutrition disorders | 0 of 3 | 0 of 3 | 2 of 7 | 1 of 3 | 4 of 15 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 0 of 3 | 1 of 3 | 3 of 7 | 2 of 3 | 1 of 15 |
| Hypophosphatasemia | Metabolism and nutrition disorders | 3 of 3 | 0 of 3 | 2 of 7 | 0 of 3 | 2 of 15 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 1 of 3 | 1 of 3 | 1 of 7 | 1 of 3 | 3 of 15 |
| Nausea | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 2 of 7 | 1 of 3 | 3 of 15 |
Serious events with the highest arm-level rate: fatigue (33.3%), hip fracture (33.3%), dehydration (28.6%), abdominal pain (14.3%), nausea (14.3%).
The adverse-event record gives, for each listed group, participants at risk and participants affected by serious adverse events and by other adverse events. For serious events, the affected counts are 1 of 3 in Phase 1b-Dose Level 1, 0 of 3 in Phase 1b-Dose Level 2, 5 of 7 in Phase 1b-Dose Level 3, 1 of 3 in Phase 1b-Dose Level 4, and 9 of 15 in Phase 2-. For other adverse events, the counts are 3 of 3, 3 of 3, 7 of 7, 3 of 3, and 14 of 15, in that group order.
The registry lists deaths as 2, 3, 5, 1, and 8 across those same groups. The cause of death, timing, and relationship to treatment are not reported in the registry record. These counts should not be interpreted as treatment-attributable deaths.
Serious adverse-event terms include Fatigue and Hip fracture at 33.3% each, Dehydration at 28.6%, and Abdominal pain, Nausea, and Vomiting at 14.3% each. The record does not report term-specific denominators or whether participants could contribute more than one event. Counts and percentages describe the registry entries; they do not establish comparative risk or causation. Since the study was non-randomized and the groups are not a like-for-like control comparison, contrasts between groups are descriptive only.
12. What the Result Does, and Does Not, Mean
The posted results describe safety events in a non-randomized, open-label study of NT-I7 with atezolizumab in high-risk melanoma, Merkel Cell Carcinoma, and cutaneous Squamous Cell Carcinoma. The registry reports serious and other adverse-event counts by listed group, as well as deaths and selected serious adverse-event terms. These data provide a descriptive account of what was recorded in the groups, but the registry does not report inferential analyses or confidence intervals for the counts.
The study’s Phase 1b objective was to evaluate safety and tolerability, including estimation of a maximum tolerated dose and/or recommended Phase 2 dose. The registry also identifies ORR as a Phase 2a primary outcome measure and lists secondary aims related to immunogenicity and anti-tumor activity. However, numerical results for ORR and the other efficacy aims are not reported in the registry record. The posted information therefore does not establish the magnitude or precision of an anti-tumor response estimate.
The trial design also limits causal interpretation. There was no randomization or masking, and the listed clinical groups differ by disease and checkpoint-inhibitor history. They are not a like-for-like control comparison. An observed difference between groups could arise from those differences or other factors, not necessarily from NT-I7 or atezolizumab. The adverse-event counts likewise cannot establish that treatment caused an event.
The registry lists the study as terminated, but the reason for termination is not reported in the registry record. The meaning of termination should not be inferred from status alone. Overall, the available record supports a cautious reading of descriptive safety counts and the stated outcome definitions. It does not provide the statistical detail or numerical efficacy results needed to establish a comparative treatment effect.
13. Why This Trial Matters Statistically
This study illustrates a common statistical distinction in early-phase research: a safety and dose-selection objective is not the same as a comparative efficacy question. Phase 1b was designed around safety and tolerability, including DLTs and estimation of a maximum tolerated dose and/or recommended Phase 2 dose. Those objectives call for careful description of events and the populations observed. They do not, by themselves, establish whether a regimen improves outcomes relative to another treatment.
The registry’s Phase 2a ORR definition makes clear what response measure was intended: the percentage with at least one confirmed partial response or complete response according to RECIST v.1.1. But without a numerical ORR estimate, uncertainty interval, or inferential analysis in the registry record, the efficacy question remains unanswered in the posted results. This is a useful reminder that an outcome definition is not an outcome result.
The non-randomized structure is also important. Groups based on cancer type, checkpoint-inhibitor history, or dose level may differ in ways that affect outcomes. Without a like-for-like control group and a reported adjustment strategy, differences across groups are descriptive rather than causal. This applies to safety counts as well as efficacy outcomes.
Finally, the record distinguishes a broader safety population from a DLT population with a specified observation window. Such population definitions are essential to interpreting event counts. But further information on missing observations, statistical methods, and dose-selection rules is not reported in the registry record. The trial therefore offers a case study in how endpoint definitions and study design shape the conclusions that registry data can support.
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.
Several limitations specific to this study restrict interpretation. It was non-randomized and open-label, with no like-for-like control comparison. The clinical groups included different cancers and different checkpoint-inhibitor histories, while the adverse-event listings are organized by Phase 1b dose level and Phase 2-. The relationship between these group descriptions is not reported in the registry record. Differences between groups should not be attributed to treatment without a design or analysis capable of supporting that claim.
The listed enrollment is 31, while the adverse-event group counts are reported separately. The registry does not provide enough detail to reconcile the group listings with all enrolled participants or to identify the analysis populations for each outcome. The safety and DLT populations have different definitions, and handling of other incomplete observations is not reported in the registry record. This limits assessment of follow-up and completeness.
The record does not report numerical ORR results, confidence intervals, inferential analyses, an adjustment strategy, or detailed statistical methods. It also does not report the trial’s sample-size justification, dose-escalation rules, or multiplicity approach. For deaths and serious adverse-event terms, cause, timing, treatment relationship, and term-specific denominators are not reported in the registry record.
The status is terminated, but the reason is not reported in the registry record. Without that context, termination cannot be interpreted as evidence about safety, efficacy, feasibility, or a decision to stop for another reason. These limitations mean the posted information is best read as descriptive safety reporting alongside stated outcome definitions, rather than as a complete evaluation of comparative efficacy or risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: High-Risk Skin Cancers With Atezolizumab Plus NT-I7 — NCT03901573.
- Registry record last updated 2025-10-22; status last verified 2025-10.
- Results first posted 2025-10-22.
- 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
NCT03901573 is a Phase 1b/2a, open-label, non-randomized, parallel study sponsored by NeoImmuneTech. It evaluated NT-I7 with atezolizumab in high-risk melanoma, Merkel Cell Carcinoma, and cutaneous Squamous Cell Carcinoma among patients described as anti-PD-1/PD-L1 naïve or relapsed/refractory. The registry lists enrollment of 31, a start date of 2019-12-26, primary completion on 2023-08-15, and status as terminated.
The Phase 1b primary objective concerns safety and tolerability, including adverse events and DLTs, with the aim of estimating a maximum tolerated dose and/or recommended Phase 2 dose. The registry defines ORR for Phase 2a but does not report a numerical ORR result. Safety counts are listed by dose-level and Phase 2- groups; the study has no randomized control comparison. Inferential analyses, detailed missing-data methods, and the reason for termination are not reported in the registry record. The posted evidence is therefore descriptive and does not establish a comparative treatment effect.