Trial Outcomes & Findings for Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy (NCT NCT04637594)
NCT ID: NCT04637594
Last Updated: 2026-03-20
Results Overview
OS is the length of time patients are alive after registering to receive protocol treatment. Patients who are lost to follow-up or are not known to be deceased at the time of study analysis will be censored at the time of last patient contact. Cox models will be used to compare the outcome between the two treatment groups.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
3 participants
Primary outcome timeframe
12 months
Results posted on
2026-03-20
Participant Flow
Participant milestones
| Measure |
Arm A (Immune Checkpoint Inhibitor)
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Immune Checkpoint Inhibitor)
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by subject prior to beginning treatment
|
0
|
2
|
Baseline Characteristics
Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy
Baseline characteristics by cohort
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 Participants
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 Participants
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=154 Participants
|
2 Participants
n=151 Participants
|
3 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=154 Participants
|
2 participants
n=151 Participants
|
3 participants
n=305 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOS is the length of time patients are alive after registering to receive protocol treatment. Patients who are lost to follow-up or are not known to be deceased at the time of study analysis will be censored at the time of last patient contact. Cox models will be used to compare the outcome between the two treatment groups.
Outcome measures
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 Participants
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 Participants
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Overall Survival (OS) Rate at 12 Months
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Post baseline assessment was completed for only 1 participant, therefore PFS cannot be calculated
Progression-free survival (PFS) is the length of time patients are alive without disease progression. Progression will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
Outcome measures
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 Participants
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 Participants
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS) Rate at 12 Months
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Post baseline assessment was completed for only 1 participant, therefore iPFS cannot be calculated
Immune-related progression-free survival (iPFS) is the length of time patients are alive without immune-related progression. Progression will be assessed using immune related (ir)RECIST criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
Outcome measures
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 Participants
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 Participants
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Immune-related Progression-free Survival (iPFS) Rate at 12 Months
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From last dose of immune checkpoint inhibitor (ICI) to initiation of a subsequent systemic treatment or death, assessed up to 5 yearsPopulation: All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
Treatment-free Interval is the length of time patients are off treatment. A Stratified Cox model will be used to evaluate this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2.5 yearsAdverse events (AEs) are ailments occurring during treatment. AEs will be assessed using Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 Participants
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 Participants
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Number of Patients Experiencing Grade 3 or Greater Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A (Immune Checkpoint Inhibitor)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B (Immune Checkpoint Inhibitor)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Immune Checkpoint Inhibitor)
n=1 participants at risk
CONTINUATION OF ICI TREATMENT:
Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
Arm B (Immune Checkpoint Inhibitor)
n=2 participants at risk
DISCONTINUATION OF ICI TREATMENT:
Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.
Pembrolizumab: Given IV
Nivolumab: Given IV
Atezolizumab: Given IV
Durvalumab: Given IV
Avelumab: Given IV
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 2 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - other
|
0.00%
0/1 • 2.5 years
|
50.0%
1/2 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • 2.5 years
|
50.0%
1/2 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Flu like symptoms
|
100.0%
1/1 • Number of events 1 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
100.0%
1/1 • Number of events 1 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • 2.5 years
|
50.0%
1/2 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
100.0%
1/1 • Number of events 1 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Infections and infestations
Papulopustular rash
|
100.0%
1/1 • Number of events 1 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
100.0%
1/1 • Number of events 2 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 2 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 1 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
0.00%
0/1 • 2.5 years
|
50.0%
1/2 • Number of events 1 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Number of events 4 • 2.5 years
|
0.00%
0/2 • 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place