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International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

Miscellaneous

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:

A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:

P. prophylactic PLND Q. no prophylactic PLND
Miscellaneous
III
Rini, Brian
NCT02305654
ECOGUROEA8134

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

Miscellaneous

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.
Miscellaneous
I
Davis, Elizabeth
NCT06561685
VICC-DTPHI24160

A Study of PHST001 in Advanced Solid Tumors

Miscellaneous

PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.
Miscellaneous
I
Davis, Elizabeth
NCT06840886
VICCPHI24591

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

Multiple Cancer Types

This study is researching an investigational drug called REGN7075 by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe and tolerable REGN7075 is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of REGN7075 to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective REGN7075 by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.

The study is also looking at:

* Side effects that may be experienced by people taking REGN7075 by itself and in combination with cemiplimab with or without chemotherapy
* How REGN7075 works in the body by itself and in combination with cemiplimab with or without chemotherapy
* How much REGN7075 is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
* To see if REGN7075 by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
Adrenocortical, Bladder, Breast, Cervical, Colon, Esophageal, GIST, Gastric/Gastroesophageal, Gastrointestinal, Gynecologic, Head/Neck, Kidney (Renal Cell), Liver, Lung, Miscellaneous, Non Small Cell, Ovarian, Pancreatic, Phase I, Prostate, Rectal, Urologic, Uterine
I/II
Choe, Jennifer
NCT04626635
VICC-DTPHI24031