*LIGHTBEAM-U01 Substudy 01B in Paediatric & Young Adult Participants

• Research type

  Research Study

• Full title

  LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors.

• IRAS ID

  1008917

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06395090

• Research summary

  Researchers are looking for new ways to treat children and young adults with relapsed or refractory blood cancers, advanced melanoma (a type of skin cancer) or solid tumours. Relapsed means the cancer has come back after it responded to a previous treatment. Refractory means the blood cancer did not respond or stopped responding to treatment. Advanced means the skin cancer has spread in the body or cannot be removed with surgery.

  Researchers want to learn if pembrolizumab, an immunotherapy, given with other immunotherapies (favezelimab or vibostolimab) can be used to treat various cancers. An immunotherapy is a treatment that helps the immune system fight cancer.

  The purpose of this trial is to learn about:
  • The safety of different doses (amounts) of immunotherapy and how well people tolerate them
  • What happens to different doses of immunotherapy in a person’s body over time
  • How many people have cancer that responds (the cancer gets smaller or goes away) after receiving immunotherapy

  Up to 80 children and young adults (birth to less than 18 years old) will be in this trial.

  People will receive treatments through a needle into a vein as an intravenous (IV) infusion. All treatments are given once every 3 weeks for about 2 years. People may be in the trial for about 5 years.

  Both the people in the trial and the researcher will know which trial treatment a person is getting. During this trial, people may give blood, urine, tumour and bone marrow samples, and have physical examinations.

  People may or may not benefit from the treatment received during the trial. This trial has an external group of experts that oversees the overall risk and benefit. If this group of experts decides that the trial treatment is not safe or does not show benefit, the trial can be stopped.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0002

• Date of REC Opinion

  22 Mar 2024

• REC opinion

  Further Information Favourable Opinion