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About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/04/2020.
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Clinical Trials of Interest

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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/04/2020.
Displaying: 4 trials in your specialties ()
View trials across your selected specialties

A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Small Cell Lung Carcinoma
View Full Trial
INTERVENTION

Drug: CC-90011, Drug: Cisplatin, Drug: Carboplatin, Drug: Etoposide, Drug: Nivolumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hospital Le Timone, Marseille Cedex 5, France

Brief Summary

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC. The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Neoplasms
View Full Trial
INTERVENTION

Drug: CC-90011, Drug: Nivolumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Augusta University - Georgia Cancer Center, Augusta, Georgia, United States

Brief Summary

This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies. The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts: - Cohort A: SCLC in ICI naïve subjects - Cohort B: SCLC in ICI progressor subjects - Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1. In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility. In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Neoplasms, Lymphoma, Non-Hodgkin
View Full Trial
INTERVENTION

Drug: CC-90011

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Centre Georges Francois Leclerc, Dijon, France

Brief Summary

Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including transformed MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

N/A

  • Status
    Not yet recruiting
  • Phase
    Phase 1
  • Condition
    Not provided
View Full Trial
INTERVENTION

Not provided

Eligibility
  • Ages:
  • Sexes: Male
  • Accepts Healthy Volunteers:
Locations

Brief Summary

N/A