Trial Outcomes & Findings for Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors (NCT NCT03108131)
NCT ID: NCT03108131
Last Updated: 2025-05-28
Results Overview
To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Efficacy as determined by complete response and partial response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Patient will be on study up to 3 years
Results posted on
2025-05-28
Participant Flow
Out of the 49 patients that was enrolled at MD Anderson Cancer Center Houston, Tx, only 20 patients had Small Bowel Adenocarcinoma. The rest had other solid tumors and their data was not used in the analysis for the group of patients with Small Bowel Adenocarcinoma.
Participant milestones
| Measure |
Small Bowel Adenocarcinoma
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors
Baseline characteristics by cohort
| Measure |
Small Bowel Adenocarcinoma
n=20 Participants
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Patient will be on study up to 3 yearsTo evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Efficacy as determined by complete response and partial response.
Outcome measures
| Measure |
Small Bowel Adenocarcinoma
n=20 Participants
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 yearsDisease Control Rate (DCR) includes patients with tumor maintained at Stable Disease (SD), Partial Response (PR) and Complete Response (CR).
Outcome measures
| Measure |
Small Bowel Adenocarcinoma
n=20 Participants
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Disease Control Rate (DCR)
|
45 percentage of participants
Interval 23.1 to 68.5
|
SECONDARY outcome
Timeframe: 3 yearsProgression free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death
Outcome measures
| Measure |
Small Bowel Adenocarcinoma
n=20 Participants
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Progression-Free Survival (PFS)
|
2.4 months
Interval 1.3 to 3.5
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 2 of the patients was not included in the analysis of PFS because their surgical cancellations were unrelated to progressive disease.
Overall survival (OS) is defined as the time from randomization to death
Outcome measures
| Measure |
Small Bowel Adenocarcinoma
n=18 Participants
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Overall Survival
|
8.8 months
Interval 5.6 to 12.0
|
Adverse Events
Small Bowel Adenocarcinoma
Serious events: 0 serious events
Other events: 9 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Small Bowel Adenocarcinoma
n=20 participants at risk
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
8/20 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • 3 years
|
|
Eye disorders
Retinopathy
|
10.0%
2/20 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
4/20 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • 3 years
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Gatroesophageal Disease
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal Disease-Others (Sore Gums)
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • 3 years
|
|
General disorders
Limb Edema
|
15.0%
3/20 • 3 years
|
|
General disorders
Fatigue
|
45.0%
9/20 • 3 years
|
|
General disorders
Fever
|
10.0%
2/20 • 3 years
|
|
General disorders
Gait Disturbances
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
UTI
|
15.0%
3/20 • 3 years
|
|
Infections and infestations
Infections and Infestations-Other (Influenza A and H1 2009
|
5.0%
1/20 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • 3 years
|
|
Investigations
Alanin aminotransferace increase
|
20.0%
4/20 • 3 years
|
|
Investigations
Alkaline Phosphatase increase
|
25.0%
5/20 • 3 years
|
|
Investigations
Aspartate aminotransferase Increase
|
25.0%
5/20 • 3 years
|
|
Investigations
Total Bilirubin Increase
|
5.0%
1/20 • 3 years
|
|
Investigations
Cholesterol High
|
10.0%
2/20 • 3 years
|
|
Investigations
CPK Increased
|
30.0%
6/20 • 3 years
|
|
Investigations
INR increased
|
5.0%
1/20 • 3 years
|
|
Investigations
Platelet Count decrease
|
5.0%
1/20 • 3 years
|
|
Investigations
White Blood Cell Count Increaese
|
10.0%
2/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
2/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Peripheral Neuropathy
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Nervous System Disorders-others (Brain Metastasis)
|
5.0%
1/20 • 3 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
5/20 • 3 years
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 3 years
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • 3 years
|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
1/20 • 3 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.0%
1/20 • 3 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.0%
1/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
5.0%
1/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
5.0%
1/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-planter Erythrodysesthesia Syndrome
|
5.0%
1/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
5.0%
1/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
10.0%
2/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
15.0%
3/20 • 3 years
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • 3 years
|
Additional Information
Dr. Kanwal Raghav
The University of Texas MD Anderson Cancer Center
Phone: (917) 733-0356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place