Short Title: CAPitello-292
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This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.
Study Number:
CAPitello-292
Study Status:
Enrolling
Treatment Agent:
Capivasertib, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
National Clinical Trial Identified Number: NCT04862663
Disease:
Study Phase:
Ib/III
researchcancer@cooperhealth.edu
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
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Short Title: MDA 2024-1159/EXPAND
The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).
Study Number:
MDA 2024-1159
Study Status:
Enrolling
Treatment Agent:
Radiation Therapy
National Clinical Trial Identified Number: NCT06593431
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease (EXPAND): A randomized phase III trial
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Short Title: CC014/PREEMPT
This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
Study Number:
CC014
Study Status:
Enrolling
Treatment Agent:
Radiation Therapy
National Clinical Trial Identified Number: NCT06745024
Disease:
Study Phase:
III
freitag-roseann@cooperhealth.edu
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
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Short Title: OPTIMICE-PCR
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Study Number:
A012103
Study Status:
Enrolling
Treatment Agent:
Pembrolizumab
National Clinical Trial Identified Number: NCT05812807
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve PCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
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Short Title: ARTEMIDE 03
The purpose of this study is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).
Study Number:
ARTEMIDE 03/D702FC00001
Study Status:
Enrolling
Treatment Agent:
Rilvegostomig, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed
National Clinical Trial Identified Number: NCT06627647
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1
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Short Title: ARTEMIDE-02
The purpose of the study is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Study Number:
ARTEMIDE-02/D702BC00001
Study Status:
Enrolling
Treatment Agent:
Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel
National Clinical Trial Identified Number: NCT06692738
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1
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