INDUCE2 : A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Head and neck,Lung,Skin,Urinary systemBladder,Cutaneous Squamous Cell Carcinoma (CSCC),Head and neck,Kidney,Lung,Melanoma (Skin),Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Non-Small Cell Lung Cancer,Nose (nasopharynx),Oral cavity,Oropharynx,Prostate,Renal cell carcinoma,Squamous cell carcinoma ,Throat (hypopharynx),Urinary tract

Trial Overview Read MoreRead more

This Phase I/II trial is evaluating how safe and tolerable the combination of two intravenous immunotherapies (GSK3359609 and tremelimumab) is for patients with select advanced solid cancers (part one), in particular patients that have relapsed or refractory squamous cell carcinoma of the head and neck (part two).
 

This trial is treating multiple types of cancer including cutaneous melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, urothelial carcinoma, clear cell renal carcinoma or castrate resistant prostate adenocarcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors

Commercial Sponsor

GlaxoSmithKline

Summary

In part one of this trial, participants with select, advanced solid cancers will scalating doses of GSK3359609 and tremelimumab in combination. In part two of the trial, participants with relapsed or refractory squamous cell carcinoma of the head and neck, who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy, will be randomised 2:1 to receive GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next