Trial Outcomes & Findings for Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (NCT NCT03300544)
NCT ID: NCT03300544
Last Updated: 2024-05-23
Results Overview
Assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
4 weeks after surgery
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
Talimogene Laherparepvec + FOLFOX + Short Course RT
Talimogene laherparepvec + FOLFOX + Short Course RT
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec + FOLFOX + Short Course RT (Radiation Therapy)
n=3 Participants
Talimogene laherparepvec + FOLFOX + Short Course RT (Radiation Therapy)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after surgeryPopulation: Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study
Assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Treatment (T-VEC, Capecitabine, Chemoradiation)
n=3 Participants
Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.
Capecitabine: Given PO
Fluorouracil: Given IV
Leucovorin: Given IV
Oxaliplatin: Given IV
Radiation Therapy: Undergo chemoradiation
Talimogene Laherparepvec: Given intralesionally
|
|---|---|
|
Determination of Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of Talimogene Laherparepvec in Combination With Chemotherapy and Radiation in Rectal Cancer.
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryPopulation: Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study
Feasibility will be reported in all patients who have started therapy as percent of planned dose intensity. The scale for dose intensity will range from 0 - 100% with a higher score being better. The result will be reported using descriptive statistics.
Outcome measures
| Measure |
Treatment (T-VEC, Capecitabine, Chemoradiation)
n=3 Participants
Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.
Capecitabine: Given PO
Fluorouracil: Given IV
Leucovorin: Given IV
Oxaliplatin: Given IV
Radiation Therapy: Undergo chemoradiation
Talimogene Laherparepvec: Given intralesionally
|
|---|---|
|
To Establish Safety and Feasibility of the Combination
|
99.5 percentage of dose intensity
Interval 99.0 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryPopulation: Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study
The NAR score has been validated in clinical trials as a surrogate endpoint for overall survival. The score is designed to be particularly sensitive to changes in factors that are affected by neoadjuvant. NAR is calculated based on the clinical T stage (cT), pathological T (pT) and pN stages as: NAR = \[5pN- 3 (cT- pT) + 12\] \^2 / 9.61 and will be reported using descriptive statistics Scale: The NAR score is a pseudo-continuous variable with 24 possible discrete scores from 0 to 100 with higher scores representing a poorer prognosis.
Outcome measures
| Measure |
Treatment (T-VEC, Capecitabine, Chemoradiation)
n=3 Participants
Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.
Capecitabine: Given PO
Fluorouracil: Given IV
Leucovorin: Given IV
Oxaliplatin: Given IV
Radiation Therapy: Undergo chemoradiation
Talimogene Laherparepvec: Given intralesionally
|
|---|---|
|
Determine the Neoadjuvant Rectal (NAR) Score of Talimogene Laherparepvec With Chemotherapy and Radiation.
|
30.07 units on a scale
Interval 0.93 to 37.56
|
Adverse Events
Treatment (T-VEC, Capecitabine, Chemoradiation)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (T-VEC, Capecitabine, Chemoradiation)
n=3 participants at risk
Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.
Capecitabine: Given PO
Fluorouracil: Given IV
Leucovorin: Given IV
Oxaliplatin: Given IV
Radiation Therapy: Undergo chemoradiation
Talimogene Laherparepvec: Given intralesionally
|
|---|---|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain (lower back)
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Investigations
Anemia
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Investigations
ANC low
|
66.7%
2/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Investigations
Platelet count low
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Nervous system disorders
Anxiety
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Cardiac disorders
Sinus Bradycardia
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Baseline up to 12 weeks
Poor enrollment due to COVID and change in standard of care led to discontinuation of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60