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Trial · NCT02661100

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

NCT02661100, Phase 1, Phase 2, Withdrawn, Case Comprehensive Cancer Center

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients. Trials, record NCT02661100. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02661100

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients
NCT number
NCT02661100
Status
Withdrawn
Phases
Phase 1, Phase 2
Enrollment
0 participants, actual
Lead sponsor
Case Comprehensive Cancer Center
Conditions
Non Small Cell Lung Cancer, Advanced Triple Negative Breast Cancer, Small Cell Lung Cancer, Urothelial Cancer, Mesothelioma, Malignant Melanoma
Interventions
Pembrolizumab, CDX-1401, Poly-ICLC
First posted
2016-01-22
Last updated
2016-12-07

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDose Limiting ToxicityUp to 28 days of therapy (Cycle 1)
Dose limiting toxicity (DLT) will be defined as any side effects which are attributable to the study treatment during the first 28 days of therapy (Cycle 1). The dose limiting toxicity will be based on the tolerability observed during treatment.
SecondaryObjective Response Rate for combination therapyUp to 24 months after beginning treatment
Tumor response will be assessed using immune-related Response Criteria (irRC). The objective response rate will be estimated based on the crude proportion of patients who achieve complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
SecondaryMedian Duration of ResponseUp to 24 months after beginning treatment
Tumor response will be assessed using immune-related Response Criteria (irRC). The duration of response will be calculated from the time when the criteria for response are first met to the first documentation of relapse (after CR) or progression (after PR). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart. Stable disease is when 50% decrease in tumor burden compared with baseline cannot be established nor 25% increase compared with baseline. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.
SecondaryMedian time to tumor responseUp to 24 months after beginning treatment
Tumor response will be assessed using immune-related Response Criteria (irRC). Complete response is defined as the disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Partial response is defined as \>=50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart. Stable disease is when 50% decrease in tumor burden compared with baseline cannot be established nor 25% increase compared with baseline. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.
SecondaryMedian time of progression free survivalUp to 24 months after beginning treatment
Time from beginning of treatment to disease progression. Progressive disease is defined as at least 25% increase in tumor burden compared with baseline in two consecutive observations at least 4 weeks apart.
SecondaryMedian Overall SurvivalUp to 24 months after beginning treatmentDefined as time from beginning of treatment until death, withdrawal of consent, or the end of the study, whichever occurs first.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02661100

GET https://conductscience.org/api/trials/v1/NCT02661100/registered