RightFit
RecruitingPhase 2

Impact of Circadian Rhythm on Immunotherapy

Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether standard cancer immunotherapy works better in the morning or afternoon. Immunotherapy helps the immune system fight cancer. The study is for people with advanced cancer or cancer that has spread who qualify for this treatment.

This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced/metastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1/PD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced cancer or cancer that has spread, and fit one of the three groups below.
  • Group A: Have non-small cell lung cancer and qualify for approved PD-1/PD-L1 immunotherapy as your first treatment.
  • Group B: Have non-small cell lung cancer and have finished up to 4 rounds of starting treatment. Your cancer must be stable or improving, and you must qualify for ongoing PD-1/PD-L1 treatment to keep it under control.
  • Group C: Have a solid tumor and qualify for approved PD-1/PD-L1 immunotherapy as your first treatment.
  • For Groups A and C, you must not have had this type of immunotherapy before. For Group B, you must have had it as part of your starting treatment.
  • Your study doctor must find that you can receive PD-1/PD-L1 treatment alone or with other FDA-approved drugs under their approved uses.
  • Be willing to have treatment at a time assigned by chance, either early in the morning or later in the day or evening.
  • Be able to read and write in English, understand the study consent form, and be willing to sign it.

Who can't join

  • Cannot receive PD-1/PD-L1 treatment because of a past allergic reaction to it or any of its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Cohort Specific Criteria * Cohort A: Advanced/metastatic NSCLC patients for which 1st line PD-1/PD-L1 therapy is on-label either alone or in combination. * Cohort B: Advanced/metastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1/PD-L1 therapy is on-label either alone or in combination. * Cohort C: Advanced/metastatic solid tumor malignancy for which first-line anti-PD-1/PD-L1 therapy is on-label either alone or in combination. 2. Prior and concurrent therapy criteria o Patients should be ICI-naïve (this should be first-line therapy) (Cohorts A and C), or should have received ICI induction therapy and are now eligible for ICI maintenance therapy (Cohort B). 3. Must be willing to be randomized to complete therapy at assigned time of day, which may be early in the morning OR later in the day/into the evening. 4. Must be eligible to receive anti-PD-1/PD-L1 therapy singly or in combination with other FDA-approved agents according to standard of care practices, as determined by the clinical judgment of the investigator but according to approved label indications 5. Must have the ability to understand and the willingness to sign a written informed consent document. 6. Able to read and write in English. Exclusion Criteria: 1\. Participant unable to receive anti-PD-1/PD-L1 therapy due to prior allergic reactions to therapy or any therapy ingredients.

Study sites (1)

PA