Microsatellite-stable Colorectal CancerPhase 2NCT04145193
Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC
A Phase 2 study testing E1 - mFOLFOX and durvalumab, E2 - mFOLFOX6, durvalumab and oleclumab and E3 - mFOLFOX6, durvalumab and monalizumab in people with Microsatellite-stable Colorectal Cancer, run by MedImmune LLC.
Trial summary
Columbia 2 is a Phase 2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX) alone and in combination with novel oncology therapies in adjuvant high-risk microsatellite-stable colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Microsatellite-stable Colorectal Cancer
- What is being tested?
- E1 - mFOLFOX and durvalumab, E2 - mFOLFOX6, durvalumab and oleclumab and E3 - mFOLFOX6, durvalumab and monalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 19 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age ≥ 18 years at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically proven Stage II or Stage III CRC
- Subjects must also meet the following criteria:
- Eligible for 6 months of mFOLFOX6 adjuvant chemotherapy within 8 weeks after surgery
Show all 13Show fewer
- Must NOT have received prior systemic chemotherapy, immunotherapy, or radiotherapy for treatment of CRC.
- Must NOT have defective DNA mismatch repair (MSI) as documented by testing
- Margin-negative (R0; defined as >1 mm clearance) surgical resection
- Postoperative ctDNA-positive status defined by the presence of ctDNA derived from plasma; determined using a validated assay per protocol
- Subjects must have adequate organ function
- Body weight > 35 kg
- Adequate method of contraception per protocol
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc").
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune disorders within the past 5 years as noted in the protocol.
- Cardiac and vascular criteria:
- History of venous thrombosis within the past 3 months prior to the scheduled first dose of study treatment.
Show all 19Show fewer
- Presence of acute coronary syndrome including myocardial infarction or unstable angina pectoris, other arterial thrombotic event including cerebrovascular accident or transient ischemic attack or stroke within the past 6 months prior to the scheduled first dose of study treatment.
- New York Heart Association (NYHA) Class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension.
- History of hypertensive crisis/hypertensive encephalopathy within the past 6 months prior to the scheduled first dose of study treatment.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
- Uncontrolled intercurrent illness, see the protocol for details.
- History of another primary malignancy except for: (a) Malignancy treated with curative intent and with no known active disease ≥ 5 years prior to the scheduled first dose of study treatment and of low potential risk for recurrence
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Known allergy or hypersensitivity to any of the investigational product or noninvestigational product formulations.
- Any condition that, in the opinion of the investigator, would prevent the initiation of 6 months adjuvant therapy within 8 weeks of surgery
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the scheduled first dose of study treatment, or anticipation of the need for major surgical procedure during the course of the study.
- Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment.
About this study
Official title: A Phase 2, Open-label, Randomized, Multicenter, Platform Study of Novel Oncology Therapies in Combination With Adjuvant Chemotherapy in High-risk, Microsatellite-stable Colorectal Cancer (COLUMBIA-2)
Columbia 2 is a Phase 2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX) alone and in combination with novel oncology therapies in adjuvant high-risk microsatellite-stable colorectal cancer
Read the detailed description
Columbia 2 is a Phase 2, open-label, randomized, multicenter, platform study of novel oncology therapies in combination with adjuvant chemotherapy in patients with high-risk microsatellite-stable colorectal cancer.
- Conditions
- Microsatellite-stable Colorectal Cancer
- Being tested
- Standard of Care - mFOLFOX6, E1 - mFOLFOX and durvalumab, E2 - mFOLFOX6, durvalumab and oleclumab, E3 - mFOLFOX6, durvalumab and monalizumab
- Keywords
- Microsatellite stable, Colon Cancer, colorectal cancer, MSS-CRC, adjuvant
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care - mFOLFOX6Drug
Also called FOLFOX (Oxaliplatin, Folinic acid (leucovorin), Fluorouracil (5-FU))
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
E1 - mFOLFOX and durvalumabDrug
Also called Durvalumab (MEDI-4736)
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle)
E2 - mFOLFOX6, durvalumab and oleclumabDrug
Also called Durvalumab (MEDI-4736) + Oleclumab (MEDI-9447)
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Oleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle)
E3 - mFOLFOX6, durvalumab and monalizumabDrug
Also called Durvalumab (MEDI-4736) + Monalizumab (IPH2201)
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Monalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (mFOLFOX6) | Active comparator | Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Receives: Drug: Standard of Care - mFOLFOX6; Drug: E1 - mFOLFOX and durvalumab; Drug: E2 - mFOLFOX6, durvalumab and oleclumab; Drug: E3 - mFOLFOX6, durvalumab and monalizumab |
| Durvalumab | Experimental | Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Receives: Drug: E1 - mFOLFOX and durvalumab; Drug: E2 - mFOLFOX6, durvalumab and oleclumab; Drug: E3 - mFOLFOX6, durvalumab and monalizumab |
| Oleclumab | Experimental | Oleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle) Receives: Drug: E2 - mFOLFOX6, durvalumab and oleclumab |
| Monalizumab | Experimental | Monalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle) Receives: Drug: E3 - mFOLFOX6, durvalumab and monalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA clearance
ctDNA clearance is defined as the change from ctDNA positive status at baseline to ctDNA negative post baseline (6 months)
Measured: From the time of first dose to 6 months post treatment
Secondary outcomes (6)
Incidence of adverse events
The secondary endpoint of safety as assessed by the number of subjects with adverse events and serious adverse events
Measured: From time of first dose to 90 days post last dose
Disease free survival
From randomization until time of first documented incidence of disease recurrence, secondary cancer, or death due to any cause, whichever occurs first
Measured: From time of first dose till end of study (5 years)
Disease free survival at 12 months
Percentage of subject who are disease free at 12 months post first dose of treatment
Measured: From time of first dose till end of study (5 years)
overall survival
From randomization until death due to any cause
Measured: From time of first dose till end of study (5 years)
Serum conenctration levels of novel agents in combination with mFOLFOX6
Pharmacokinetics of novel agents in combination with FOLFOX
Measured: From Day 1 up to 90 days post last dose
Number of subjects with detectable anti-drug antibody (ADA) to novel agents in combination with mFOLFOX6
Immunogenicity of novel agents in combination with mFOLFOX6
Measured: From Day 1 up to 90 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Oct 2020 (estimated)
- Primary completion19 Mar 2024 (estimated)
- Study completion19 Mar 2024 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to changing standard of care landscape.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite-stable Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study is designed to evaluate the efficacy and safety of standard-of-care adjuvant mFOLFOX6 chemotherapy alone or in combination with novel oncology therapies. The study will be conducted in subjects who have undergone radical surgical resection for Stage II or III MSS-CRC, are eligible for mFOLFOX6 adjuvant therapy, and are confirmed as ctDNA positive post-surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145193
- Sponsor's protocol ID
- D910CC00002
- Status last verified
- Sep 2020
- First submitted
- 16 Oct 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Randomized, Multicenter, Platform Study of Novel Oncology Therapies in Combination With Adjuvant Chemotherapy in High-risk, Microsatellite-stable Colorectal Cancer (COLUMBIA-2)
- ClinicalTrials.gov ID
- NCT04145193
- Acronym / sponsor ID
- D910CC00002
- Conditions
- Microsatellite-stable Colorectal Cancer
- Keywords
- Microsatellite stable, Colon Cancer, colorectal cancer, MSS-CRC, adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment due to changing standard of care landscape.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 19 Mar 2024 (estimated)
- Study completion
- 19 Mar 2024 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Columbia 2 is a Phase 2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX) alone and in combination with novel oncology therapies in adjuvant high-risk microsatellite-stable colorectal cancer
Detailed description
Columbia 2 is a Phase 2, open-label, randomized, multicenter, platform study of novel oncology therapies in combination with adjuvant chemotherapy in patients with high-risk microsatellite-stable colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is designed to evaluate the efficacy and safety of standard-of-care adjuvant mFOLFOX6 chemotherapy alone or in combination with novel oncology therapies. The study will be conducted in subjects who have undergone radical surgical resection for Stage II or III MSS-CRC, are eligible for mFOLFOX6 adjuvant therapy, and are confirmed as ctDNA positive post-surgery.
| Arm | Type | Receives |
|---|---|---|
| Control Arm (mFOLFOX6) | Active comparator | Drug: Standard of Care - mFOLFOX6, Drug: E1 - mFOLFOX and durvalumab, Drug: E2 - mFOLFOX6, durvalumab and oleclumab, Drug: E3 - mFOLFOX6, durvalumab and monalizumabParts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). |
| Durvalumab | Experimental | Drug: E1 - mFOLFOX and durvalumab, Drug: E2 - mFOLFOX6, durvalumab and oleclumab, Drug: E3 - mFOLFOX6, durvalumab and monalizumabDurvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) |
| Oleclumab | Experimental | Drug: E2 - mFOLFOX6, durvalumab and oleclumabOleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle) |
| Monalizumab | Experimental | Drug: E3 - mFOLFOX6, durvalumab and monalizumabMonalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle) |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age ≥ 18 years at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically proven Stage II or Stage III CRC
- Margin-negative (R0; defined as >1 mm clearance) surgical resection
Key exclusion criteria (19 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc").
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune disorders within the past 5 years as noted in the protocol.
- Cardiac and vascular criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care - mFOLFOX6Also: FOLFOX (Oxaliplatin, Folinic acid (leucovorin), Fluorouracil (5-FU))Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). | Drug | Control Arm (mFOLFOX6) |
| E1 - mFOLFOX and durvalumabAlso: Durvalumab (MEDI-4736)Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) | Drug | Control Arm (mFOLFOX6), Durvalumab |
| E2 - mFOLFOX6, durvalumab and oleclumabAlso: Durvalumab (MEDI-4736) + Oleclumab (MEDI-9447)Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Oleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle) | Drug | Control Arm (mFOLFOX6), Durvalumab, Oleclumab |
| E3 - mFOLFOX6, durvalumab and monalizumabAlso: Durvalumab (MEDI-4736) + Monalizumab (IPH2201)Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Monalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle) | Drug | Control Arm (mFOLFOX6), Durvalumab, Monalizumab |
Primary outcome
ctDNA clearance
Time frame: From the time of first dose to 6 months post treatment
ctDNA clearance is defined as the change from ctDNA positive status at baseline to ctDNA negative post baseline (6 months)
6 secondary outcomes
Incidence of adverse events
Time frame: From time of first dose to 90 days post last dose
Disease free survival
Time frame: From time of first dose till end of study (5 years)
Disease free survival at 12 months
Time frame: From time of first dose till end of study (5 years)
overall survival
Time frame: From time of first dose till end of study (5 years)
Serum conenctration levels of novel agents in combination with mFOLFOX6
Time frame: From Day 1 up to 90 days post last dose
Number of subjects with detectable anti-drug antibody (ADA) to novel agents in combination with mFOLFOX6
Time frame: From Day 1 up to 90 days post last dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E1 - mFOLFOX and durvalumab, E2 - mFOLFOX6, durvalumab and oleclumab and E3 - mFOLFOX6, durvalumab and monalizumab in people with Microsatellite-stable Colorectal Cancer, run by MedImmune LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA clearance (time frame: From the time of first dose to 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.