Publications by authors named "Christine McLeod"

We report the basal cell cancer (BCC) cohort of the SWOG/NCI 1609 Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors (DART), a phase II prospective, multicenter basket trial of nivolumab and ipilimumab. The primary endpoint was objective response rate (ORR) (RECIST v1.1).

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Background: Anti-programmed death-1 (PD-1)/cytotoxic T lymphocyte antigen-4 antibodies are efficacious in various malignancies.

Objectives: This study presents the first results of ipilimumab-nivolumab in invasive mucinous or non-mucinous lepidic adenocarcinoma (invasive mucinous adenocarcinoma (IMA) or invasive non-mucinous lepidic adenocarcinomas (INLA), respectively) of the lung.

Design: Dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) is a prospective, open-label, multicenter (1016 US sites), multi-cohort phase II trial of ipilimumab (1 mg/kg intravenously (IV) every 6 weeks) plus nivolumab (240 mg IV every 2 weeks).

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Article Synopsis
  • The SWOG S1609 DART trial investigated the effectiveness of dual therapy with ipilimumab and nivolumab in patients with vulvar cancers, showing initial promising results.
  • In this phase II clinical trial involving 16 patients, the objective response rate was 18.8%, with some patients exhibiting durable responses and stable disease.
  • Adverse effects were common, including diarrhea and fatigue, with 25% of patients experiencing severe side effects, highlighting the need for ongoing studies to identify response and resistance markers.
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  • The study assesses the effectiveness of a dual checkpoint inhibition therapy (ipilimumab and nivolumab) on advanced non-epithelial ovarian cancers (NEOCs) in patients who have no other effective treatments available.
  • In a clinical trial involving 17 patients, the therapy showed a 25% overall response rate in those with granulosa cell tumors, with some patients experiencing significant progression-free survival and overall survival benefits.
  • However, the therapy had serious side effects, leading to treatment discontinuation in 18% of participants and no positive responses noted in carcinosarcoma cases.
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  • Dual inhibition using ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) was tested on patients with desmoid tumors in a phase II clinical trial to assess efficacy and safety in treating these rare solid tumors.
  • The study involved 16 patients, with an overall response rate (ORR) of 18.8%, and a clinical benefit rate (CBR) of 62.5%, indicating decent stability and response to treatment over an average of 19.4 months of progression-free survival (PFS).
  • Adverse events were common, with fatigue, nausea, and hypothyroidism reported, highlighting the need for careful monitoring during treatment.
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Objectives: Multiple common cancers benefit from immunotherapy; however, less is known about efficacy in rare tumors. We report the results of the adrenocortical carcinoma cohort of NCI/SWOG S1609 Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors.

Design/setting: A prospective, phase 2 clinical trial of ipilimumab plus nivolumab was conducted by the SWOG Early Therapeutics and Rare Cancers Committee for multiple rare tumor cohorts across >1,000 National Clinical Trial Network sites.

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Background: The authors previously reported the results of the nonpancreatic neuroendocrine neoplasm cohort of the SWOG S1609 DART (Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors) trial, which permitted all histologic grades and had a 44% overall response rate (ORR) among patients with high-grade disease. Here they sought to validate their findings in a dedicated prospective cohort of high-grade neuroendocrine neoplasms within S1609.

Methods: A prospective, open-label, multicenter, phase 2 clinical trial of ipilimumab plus nivolumab was conducted across multiple rare tumor cohorts.

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Purpose: Immune checkpoint blockade has improved outcomes across tumor types; little is known about the efficacy of these agents in rare tumors. We report the results of the (nonpancreatic) neuroendocrine neoplasm cohort of SWOG S1609 dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART).

Patients And Methods: We performed a prospective, open-label, multicenter phase II clinical trial of ipilimumab plus nivolumab across multiple rare tumor cohorts, with the (nonpancreatic) neuroendocrine cohort reported here.

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